Page 1 Impella 5.5 ® with SmartAssist ® For Use During Cardiogenic Shock Instructions for Use & Clinical Reference Manual...
Page 2 Information contained in this document is subject to change without notice. ©2024 Abiomed , Inc. All rights reserved. ® The ABIOMED logo, ABIOMED, Impella 5.5 ® with SmartAssist ® and Recovering Hearts. Saving Lives. are registered trademarks of ABIOMED, Inc. in the U.S. and in certain foreign countries.
Page 3 IMPELLA 5.5 WITH SMARTASSIST ® ® USE DURING CARDIOGENIC SHOCK INSTRUCTIONS FOR USE AND CLINICAL REFERENCE MANUAL (UNITED STATES ONLY) Rx Only Abiomed, Inc. 22 Cherry Hill Drive Danvers, MA 01923 978-646-1400 (voice) 978-777-8411 (fax) clinical@abiomed.com (email) Abiomed Europe GmbH...
Page 4: Table Of Contents
Alternate Insertion Technique Using a Sidearm Graft & Silicone Plugs ..5.14 Direct Aortic Insertion with Axillary Introducer ......... 5.18 9 GENERAL SYSTEM INFORMATION Positioning & Starting Impella 5.5 with SmartAssist Catheter ....5.22 Terminology, Abbreviations, and Symbols ..........9.1 Use of the Repositioning Unit ..............5.23 Automated Impella Controller Mechanical Specifications ......
Page 5 RCTs vs. Patients Likely to be Excluded From RCTs Figure 5.14 Removing the Peel-Away Introducer ........5.13 (“Salvage” Patients) ..............6.51 Figure 5.15 Axillary Artery Insertion of the Impella 5.5 Catheter Using Figure 6.23 Kaplan-Meier Curve Estimates for 30-day Survival ....6.52 a Sidearm Graft ............... 5.14 Figure 6.24 Survival to Discharge in AMICS Cohort ........
Page 6 Table 6.11b Subgroup of STS Mortality Score ≥10 Figure 7.11 Repositioning Complete ............7.15 (Per-Protocol Population) ............6.19 Figure 7.12 Impella 5.5 with SmartAssist Position in Aorta ......7.16 Table 6.12a Individual MAE Components (ITT Population) Figure 7.13 Impella 5.5 with SmartAssist Catheter Position Unknown ..7.17 Non-Hierarchical ..............
Page 7 Table 9.14 Alarm Delay Information ............9.14 Table 6.34 In-hospital Deaths CEC-Adjudicated as Table 9.15 Impella 5.5 with SmartAssist Catheter Parameters ....9.15 Related to the Procedure ............6.86 Table 9.16 Impella 5.5 with SmartAssist Pump Metrics ......9.16 Table 6.36 Primary Endpoint - Survival at 30 Days Post-Implant or Discharge, whichever is Longer ..........
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Page 9: Introduction
It contains clinical and technical information to guide healthcare professionals in their use of the Impella 5.5 Catheter to treat cardiogenic shock. To use the system you must understand and follow these instructions. The Impella 5.5 may be used only for its intended purpose.
Page 10: Indications, Contraindications, And Potential Adverse Events
1 INDICATIONS, CONTRAINDICATIONS, AND POTENTIAL ADVERSE EVENTS INDICATIONS (UNITED STATES) ..............1.1 PMA Approved Indication ................1.1 CONTRAINDICATIONS (UNITED STATES)............1.1 POTENTIAL ADVERSE EVENTS (UNITED STATES) ......... 1.1...
Page 11: Indications (United States)
INDICATIONS (UNITED STATES) PMA APPROVED INDICATION Cardiogenic Shock The Impella 5.5 with SmartAssist System is a temporary ventricular support device intended for ® ® short term (14 days) use and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (<...
Page 12: Warnings And Cautions
2 WARNINGS AND CAUTIONS WARNINGS ....................2.1 CAUTIONS ....................2.4...
Page 13: Warnings
Consequently, the first use of Impella should be preceded by the completion of a contemporary Abiomed Impella training program and include on-site proctoring during the first use by Abiomed clinical support personnel certified in the use of Impella.
Page 14 Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Impella System, including cables specified by Abiomed. Otherwise, degradation of the performance of this equipment could result.
Page 15 (CPR). In addition, active CPR maneuvers may change the position of the Impella Device, introducing the risk of cardiac or vascular injury (including ventricular perforation). Check that the pump is positioned correctly after CPR with echocardiography guidance. Impella 5.5 ® with SmartAssist ®...
Page 16: Cautions
Rotational atherectomy, with or without the use of hemodynamic support, should be used in accordance with the manufacturer’s instructions for use. Use only original accessories and replacement parts supplied by Abiomed. Do NOT use damaged or contaminated connector cables.
Page 17 Manual Cardiac Outputs must be entered every 8 hours, or when there is a change in compliance. After 8 hours Cardiac Outputs are disabled. LV Placement Signal is disabled at P-3 and below. Impella 5.5 ® with SmartAssist ®...
Page 18: The Impella Catheter And Automated Impella Controller
3 THE IMPELLA CATHETER AND AUTOMATED IMPELLA CONTROLLER ™ OVERVIEW ....................3.1 Reusable System Components ................. 3.1 Single-use System Components ...............3.2 Impella Axillary Insertion Kit ................3.2 System Configurations ..................3.2 IMPELLA CATHETER ..................3.3 AUTOMATED IMPELLA CONTROLLER ............3.5 PURGE CASSETTE ..................3.6 ACCESSORIES ....................3.8...
Page 19: Overview
OVERVIEW The Impella Catheter is an intravascular microaxial blood pump that supports a patient’s circulatory system. The Impella 5.5 Catheter is inserted via surgical cut-down through the axillary artery and into the left ventricle. Figure 3.1 Impella Catheter in the Heart When properly positioned, the Impella Catheter delivers blood from the inlet area, which sits inside the left ventricle, through the cannula, to the outlet opening in the ascending aorta.
Page 20: Figure 3.2 Set-Up Configuration Of The Automated Impella Controller, Impella 5.5 Catheter
20 cm length Hemashield Platinum graft SYSTEM CONFIGURATIONS System configuration for Impella 5.5 Discard the Extension Figure 3.2 illustrates how the Automated Impella Controller connects to the Impella 5.5 Catheter Tubing and accessory components in the initial set-up configuration. If included, after opening...
Page 21: Impella Catheter
5.5 liters of blood per minute from the left ventricle into the aorta. Figure 3.3 illustrates the Impella Catheters. Table 3.2 describes each component from the inlet area at one end to the check valve on the other end. Figure 3.3 Impella 5.5 with SmartAssist Catheter Impella 5.5 ®...
Page 22 Cannula The cannula (21 Fr for the Impella 5.5) has a spiral-shaped reinforced body that is angled for the Impella 5.5 Catheter. The cannula is made of nitinol and covered in polyurethane. Outlet area The proximal end of the cannula is attached to the outlet area where the blood exits the cannula.
Page 23: Automated Impella Controller
Automated Impella Controller operation is described in detail in Section 4 of this manual. Automated Impella Controller Power Cord Use caution when moving equipment to prevent damaging the controller’s power cord. Figure 3.4 Automated Impella Controller – Front View Impella 5.5 ® with SmartAssist ® System...
Page 24: Purge Cassette
When the purge cassette is properly installed in the Automated Impella Controller, the Abiomed logo is upright and facing you. Figure 3.5 illustrates the purge cassette and related components. Table 3.3 describes each component.
Page 25 Purge extension line Allows for universal compatibility with Impella products. Users with the Impella 5.5 displayed in figure 3.3 will disconnect and discard the extension line, connecting the proximal yellow luer directly to the check valve. The purge extension line consists of the following components: •...
Page 26: Accessories
Table 3.4 Impella Catheter and Automated Impella Controller Accessories Component Description The Impella Axillary Insertion kit facilitates placement of the Impella 5.5 Catheter via the axillary artery. It contains a 23 Fr diameter x 6 cm length peel-away introducer and two (2) graft Guidewire Use locks used to attach a graft onto the introducer.
Page 27: Figure 3.10 3Pt Fixation Accessory
Figure 3.11 Dextrose Solution The Automated Impella Controller cart holds the Automated Impella Controller. The cart has wheels for easy transport of the controller and a storage basket. Figure 3.12 Automated Impella Controller Cart Impella 5.5 ® with SmartAssist ® System...
Page 28: Using The Automated Impella Controller
4 USING THE AUTOMATED IMPELLA CONTROLLER ™ OVERVIEW ........................4.1 AUTOMATED IMPELLA CONTROLLER FEATURES ..........4.1 HOME SCREEN ......................4.5 PLACEMENT SCREEN ....................4.9 Ao & LV Placement Signal Waveforms ..............4.9 Motor Current Waveform .................4.9 PURGE SCREEN ....................... 4.11 Purge Flow ....................4.11 Purge Pressure ....................
Page 29: Overview
Figure 4.1 illustrates the features on the front of the Automated Impella Controller. These features are described in Table 4.1. Figure 4.1 Automated Impella Controller Features – Front View Impella 5.5 ® with SmartAssist ®...
Page 30 Table 4.1 Automated Impella Controller Front View Features Feature Description Display screen Displays user information, including the labels for the soft buttons. (Display screen elements described in detail later in this section.) Soft buttons Display, open, and close menus. The function for each soft button is defined by labels adjacent to the button on the display screen;...
Page 31: Figure 4.2 Automated Impella Controller Features - Side Views
Ethernet Port External VGA Output Purge Cassette Door Release VGA OUT USB Connector Service Ethernet Jack Equipotential Ground Stud AC Plug AC Fuses Power Switch Figure 4.2 Automated Impella Controller Features – Side Views Impella 5.5 ® with SmartAssist ® System...
Page 32 VGA OUT Connection for connecting the controller to another monitor to slave the display USB connector Interface for data transfer by Abiomed maintenance or service personnel Service Connection used by Abiomed maintenance or service personnel AC fuses Electrical safety device in the event of current overload...
Page 33: Home Screen
Instructions for Use Manual do not display the header. This is for the purpose of the manual only. The header is present on all screens during use. Figure 4.3 Home Screen with Pump Metrics enabled Impella 5.5 ® with SmartAssist ® System...
Page 34 Table 4.3 Automated Impella Controller Display Elements Display Element Description Alarm window The alarm window displays up to 3 alarms simultaneously, in order of priority from top to bottom. For each alarm, the alarm window displays: • Alarm header – displayed in the left column; window is color-coded red for critical alarms, yellow for serious alarms, white for advisory notifications, gray for resolved alarms •...
Page 35 • If the system is unable to calculate flow, a yellow triangular caution icon is displayed with the message “Flow Calculation Disabled” Catheter operation icon • The circular catheter operation icon rotates when the Impella Catheter is running Impella 5.5 ® with SmartAssist ® System...
Page 36 Table 4.3 Automated Impella Controller Display Elements (continued) Display Element Description Central display area On the home screen, the central display area displays a heart pictogram and Impella Catheter position indicator message. Heart pictogram appears in the center of the home screen display. •...
Page 37: Placement Screen
When disabled, dashes are shown in place of values. The LV waveform can be disabled temporarily by pressing the DISPLAY soft button and selecting Disable LV Signal. The waveform can be re-enabled following the same steps. Impella 5.5 ® with SmartAssist ®...
Page 38 To the right of the waveforms is a display that labels the waveform, provides the units of measurement, and shows the maximum and minimum values and the average value from the samples received. At the bottom of that window is the time scale, which you can set by pressing the DISPLAY soft button.
Page 39: Purge Screen
The alarm clears when you press the MUTE ALARM button. This alarm is disabled by default. To enable this alarm, press MENU, select Settings/Service, and select Enable Purge Flow Change Notification. 4.11 Impella 5.5 ® with SmartAssist ®...
Page 40: Purge Infusion History Screen
PURGE PRESSURE The Automated Impella Controller regulates purge pressure, the pressure of the purge fluid delivered through the catheter to the motor. The purge pressure generated by the purge cassette is displayed in mmHg. The standard scale for the purge pressure (0–1500 mmHg) is displayed to the left of the purge pressure plot.
Page 41: Lvedp/Co Trend Screen
Placement Signal Low condition is detected or the position is in the Aorta or Ventricle. Figure 4.7 below shows a sample trend screen. Figure 4.7 LVEDP/CO Trend Screen 4.13 Impella 5.5 ® with SmartAssist ® System...
Page 42: Mobile Operation
MOBILE OPERATION The Li-Ion batteries must be charged for 5 hours prior to system operation in order to meet the runtime requirement of 1 hour. Failure to do so will yield a shorter runtime. After being unplugged, the Automated Impella Controller will operate for at least 60 minutes after the batteries have been fully charged.
Page 43 Page intentionally left blank 4.15 Impella 5.5 ® with SmartAssist ® System...
Page 44: Using The Automated Impella Controller With The Impella Catheter
Connect the Impella Catheter ................5.7 Enter Purge Fluid Data ..................5.9 AXILLARY INSERTION OF THE IMPELLA 5.5 CATHETER ........5.11 Alternate Insertion Technique Using a Sidearm Graft & Silicone Plugs .... 5.15 DIRECT AORTIC INSERTION WITH AXILLARY INTRODUCER ......5.18 Alternate Direct Insertion Technique with Silicone Plugs .........
Page 45: Pre-Support Evaluation
• Coronary computed tomography • Aortic valve stenosis / calcification angiography (CTA) • Moderate to severe aortic insufficiency • Ultrasound • RV failure • Echocardiography • Minimal 7 mm vessel diameter (Impella 5.5) • Complex anatomy Impella 5.5 ® with SmartAssist ® System...
Page 46: Startup
SUPPLIES NEEDED • Automated Impella Controller • Impella 5.5 with SmartAssist Catheter • Diagnostic catheter (AL1 or MP without side holes or pigtail with or without side holes) • 500 cc bag of dextrose solution for purge solution in water (5% recommended; 5% to 20%...
Page 47: Turning On The Automated Impella Controller
(see Figure 5.2). self-check to check the functionality of the alarm. If the system test fails, the controller displays a system self check failure message: SYSTEM SELF CHECK FAILED. CHANGE CONSOLE IMMEDIATELY. Impella 5.5 ® with SmartAssist ® System...
Page 48: Figure 5.2 Automated Impella Controller Startup Screen
THE STARTUP SCREEN The startup screen (see Figure 5.2) appears when you successfully turn on the Automated Impella Controller. Check Date and Time The current date and time appear at the top of the startup screen. Confirm that these are correct. For more information, refer to Appendix B Figure 5.2 Automated Impella Controller Startup Screen...
Page 49: Case Start
Do not attempt to rinse and reinsert the device after initial insertion. Hold the surgical towel or 4 x 4 gauze pad away from the inflow and outflow windows, when controlling blood splatter during insertion of the impella heart pump through the introducer. Impella 5.5 ® with SmartAssist ®...
Page 50: Figure 5.3 Initial Case Start Screen
CASE START Press the START NEW CASE soft button from the startup screen or plug in a new Impella Catheter. Case Start can also be initiated by pressing the MENU soft key and then selecting Case Start. The controller displays the screen shown in Figure 5.3. Figure 5.3 Initial Case Start Screen Instructions for Use and Clinical Reference Manual (US)
Page 51: Figure 5.4 Inserting Purge Cassette Into Automated Impella Controller
Inspect the cable for damage, including damage to the connector pins at the controller end. Shaded Steps Pass the sterile connector cable from the Impella Catheter off the sterile field. All shaded steps require sterile technique. Impella 5.5 ® with SmartAssist ® System...
Page 52: Figure 5.5 Connecting Impella Catheter
Open the cover on the blue catheter plug by rotating clockwise. Line up the notch on the connector cable with the notch in the blue catheter plug on the front of the Automated Impella Controller and plug the cable into the controller. See Figure 5.5 on next page.
Page 53: Figure 5.7 Connecting The Luer To The Impella Catheter
To select the default values displayed on the screen, press the ACCEPT soft button. This will select those values and automatically advance to the next screen. Note: the Automated Impella Controller will use the default values for the purge fluid unless changed. Impella 5.5 ® with SmartAssist ®...
Page 54: Figure 5.9 Changing The Purge Fluid Information
To change the purge fluid information, press the EDIT soft button, scroll to the appropriate item and push the selector knob to select it or use the white arrow soft keys. Then scroll through the values and push the selector knob or press SELECT to make a new selection.
Page 55: Axillary Insertion Of The Impella 5.5 Catheter
AXILLARY INSERTION OF THE IMPELLA 5.5 CATHETER NOTE – Proper surgical procedures and techniques are the responsibility of the medical professional. The described procedure is furnished for information purposes only. Each physician must evaluate the appropriateness of the procedure based on his or her medical training and experience, the type of procedure, and the type of systems used.
Page 56: Figure 5.10 Introducer, Graft Lock, And Hemashield Platinum Graft (Graft Not Supplied)
A smaller diameter graft will not fit over the introducer. Abiomed recommends the use of a 20 cm length graft to allow enough length to fully insert the Impella Catheter cannula into the graft prior to releasing vascular clamps at the anastomosis to minimize blood loss through the cannula.
Page 57: Figure 5.11 Correct Positioning If Second Graft Lock Required
0.018 inch placement guidewire to coat the hemostatic valve with silicone oil to facilitate insertion of the Impella Catheter through the hemostatic valve assembly. Once fully inserted, remove the dilator, keeping the 0.018 inch placement guidewire in place. 5.13 Impella 5.5 ® with SmartAssist ® System...
Page 58: Figure 5.13 Releasing The Graft Lock
Clamp the graft with a vascular clamp just above the anastomosis to avoid blood loss through the pump cannula during insertion through the valve. While maintaining guidewire position, backload the Impella Catheter onto the 0.018 inch placement guidewire and advance the catheter over the guidewire through the introducer into the graft such that the entire pump cannula and motor housing resides in the graft and only the catheter shaft is seen exiting the valve.
Page 59: Alternate Insertion Technique Using A Sidearm Graft & Silicone Plugs
When the aortic waveform is present, pull the catheter back an additional 3cm for Impella 5.5 with SmartAssist. (The distance between adjacent markings on the catheter is 1 cm.) Pull the yellow pin from the catheter anchor to secure the catheter in place.
Page 60: Figure 5.15 Axillary Artery Insertion Of The Impella 5.5 Catheter Using A Sidearm Graft
Backload the Impella 5.5 Catheter onto the 0.018 inch guidewire (as described in the steps in previous step 11). With the graft held at the base, place the Impella 5.5 Catheter into the open end of the graft up to the level of the silicone plug.
Page 61 Close the wound over the trimmed graft with the end of the blue suture hub clearly visible. The steering catheter for the Impella 5.5 can be manipulated if needed. If there is slack in the catheter, follow steps a-d below.
Page 62: Direct Aortic Insertion With Axillary Introducer
An incision larger than 6 mm may allow the front plug to advance into the aorta. The Impella 5.5 Catheter is surgically implanted when there is access to the ascending aorta through a sternotomy or thoracotomy. Transesophageal echocardiography (TEE) is required to guide placement.
Page 63 *If the patient is receiving a GP IIb-IIIa inhibitor, the Impella 5.5 Catheter can be inserted when ACT is 200 or above. Remove the protective sleeve on the provided 8 Fr silicone-coated lubrication dilator, being careful to avoid getting silicone on your hands.
Page 64 Anchor the hub securely to the skin. If there is slack in the catheter, remove the excess slack. Verify placement with fluoroscopy/TEE and with the placement signal. If the Impella 5.5 Catheter advances GP IIb-IIIa Inhibitors too far into the left ventricle and the controller displays a ventricular waveform rather than an aortic waveform, follow steps a-c below.
Page 65: Figure 5.16 Impella 5.5 Catheter With Silicone Plugs
Figure 5.16 Impella 5.5 Catheter with Silicone Plugs in length to prevent the front With the graft clamped at the base, place the Impella 5.5 Catheter into the open end of silicone plug from advancing into the aorta through the the graft up to the level of the rear plug.
Page 66: Positioning & Starting Impella 5.5 With Smartassist Catheter
Press START IMPELLA soft button to open the P-level menu (see Figure 5.17). Turn the selector knob to increase the P-level from P-0 to P-2. Figure 5.17 Starting the Impella 5.5 with SmartAssist Catheter Press the selector knob to select the new P-level. Increase the P-level to P-9 to confirm correct and stable placement.
Page 67: Use Of The Repositioning Unit
Impella plug by tightening the anchoring ring. Select the lowest P-level that will enable you to achieve the highest flow rate necessary for patient support. You can select one of ten P-levels (P-0 to P-9) for the Impella 5.5 Catheter (see Table 5.2 ).
Page 68: P-Level
P-LEVEL In P-LEVEL mode you can select one of ten P-levels (P-0 to P-9) for the Impella 5.5 with SmartAssist Catheter (see table below). Select the lowest P-level (P-2 or higher) that will enable you to achieve the highest flow rate necessary for patient support.
Page 69: Adjusting The Lv Placement Signal
24 hours of pump use. Note: If no suggested adjustment is available, do not adjust LV Placement Signal. If dextrose concentration is changed, LV Placement Signal should be adjusted. 5.25 Impella 5.5 ® with SmartAssist ®...
Page 70: Figure 5.20 Pump Metrics Ifu Post-Calibration In Lv Adjust Tool
To adjust LV Placement Signal: Press the MENU soft buttons. Select “Adjust LV Signal” option with rotary knob Adjust the waveform using toggle arrows or rotary knob. The LV Adjustment defaults to the suggested adjustment value. Press DONE to confirm suggested adjustment. LV waveform adjustments occur in increments of 1 mmHg from -60 to 60 mmHg.
Page 71: Entering Cardiac Output
Enter the total Cardiac Output, which can be any value from 0.0 to 10.0 L/min in increments of 0.1 L/min (Figure 5.22). Press the DONE soft button or the rotary knob to complete. Figure 5.22 Pump Metrics IFU Enter Cardiac Output tool 5.27 Impella 5.5 ® with SmartAssist ® System...
Page 72: Figure 5.23 Cardiac Output Confirmation
A Cardiac Output Confirmation will be displayed if a total Cardiac Output is entered that is less than or equal to the current Impella Flow (Figure 5.23). The CONFIRM soft button will use the current Impella Flow as the total Cardiac Output entry and the Native Cardiac Output will not be trended.
Page 73: Figure 5.24 Pump Metrics Ifu Yellow Cpo
A white reminder will also be displayed to update the CO if the Automated Impella Controller detects a significant change in the vascular state. This notification will be triggered if the average NCO or PP diverges from their initial values by a significant amount. 5.29 Impella 5.5 ® with SmartAssist ®...
Page 74: Purge Cassette Procedures
PURGE CASSETTE PROCEDURES When replacing the purge cassette or purge fluid, the replacement process should be completed within 90 Seconds of disconnecting the luer. The Impella Catheter may be damaged if replacement takes longer than 90 Seconds of disconnecting the luer. There are three procedures for maintaining the Impella Catheter purge system: •...
Page 75 Confirm that no air remains in the purge tubing. If air remains, press BACK to repeat the air removal process. Connect the purge tubing to the luer on the Impella Catheter to complete the de-air procedure. 5.31 Impella 5.5 ® with SmartAssist ® System...
Page 76: Troubleshooting The Purge System
AIR DETECTED ALERT During any of the purge system processes above, the controller automatically monitors for air in the system. If air is detected in the system, the controller provides an alert to disconnect the luer, as shown in Figure 5.26. Once the luer is disconnected, the controller automatically de-airs the purge system.
Page 77: Patient Weaning
Follow institutional guidelines for arterial closure. Disconnect the connector cable from the Automated Impella Controller and turn the controller off by pressing the power switch on the side of the controller for 3 seconds. 5.33 Impella 5.5 ® with SmartAssist ®...
Page 78 CPO with the new mean arterial pressure and cardiac output entry. See Section 4 for more information. REMOVING THE IMPELLA 5.5 CATHETER The Impella Catheter can be removed after weaning when the introducer is still in place or when the catheter is secured with the repositioning sheath.
Page 79 • Amputating the vascular graft and sewing the small end-to-side remnant closed by hand • Using a vascular stapler to close the graft near the surface of the aorta • Removing the complete graft with local patch closure, if necessary 5.35 Impella 5.5 ® with SmartAssist ®...
Page 80: Clinical Experience
6 CLINICAL EXPERIENCE CLINICAL EXPERIENCE OVERVIEW FOR HRPCI ..........6.1 PROTECT I CLINICAL STUDY ................6.1 PROTECT II PIVOTAL CLINICAL STUDY DESIGN ........... 6.2 External Evaluation Groups ................6.3 Pre-specified Statistical Analysis Plan ...............6.3 Clinical Inclusion and Exclusion Criteria ............6.4 ACCOUNTABILITY OF PROTECT II COHORT ..........6.6 Intent-to-Treat Population ................6.6 Per-Protocol Analysis Population ..............6.6 LIMITATIONS OF INTERPRETATION OF STUDY RESULTS ......6.7...
Page 81 CLINICAL EXPERIENCE (CONTINUED) SUMMARY OF SUPPLEMENTAL CLINICAL INFORMATION ......6.47 Real-World Impella Registry Results (for all Impella Devices) ..................6.47 Additional Analysis of the Impella Registry Data ..........6.50 Benchmarking Impella vs. Approved VAD in AMICS ........6.52 Hemodynamic Effectiveness Results ............... 6.55 Literature Review ...................6.57 CARDIAC SHOCK AFTER OPEN HEART SURGERY - SUMMARY OF PRIMARY CLINICAL STUDIES ..........
Page 82 Instructions for Use and Clinical Reference Manual (US)
Page 83: Clinical Experience Overview For Hrpci
PCI. The FDA reviewed this data in consideration for approval of the PROTECT II trial based on PROTECT I meeting its primary and secondary endpoints. Impella 5.5 ® with SmartAssist ®...
Page 84: Protect Ii Pivotal Clinical Study Design
PROTECT II PIVOTAL CLINICAL STUDY DESIGN The main clinical study (PROTECT II) was a prospective, multi-center, randomized, controlled clinical study. The objective of the PROTECT II study was to assess the safety and efficacy of the Impella 2.5 compared to the intra-aortic balloon pump (IABP) when used in subjects undergoing non-emergent high-risk PCI.
Page 85 EXTERNAL EVALUATION GROUPS The study was sponsored by Abiomed. The sponsor contracted with Harvard Clinical Research Institute (HCRI), an academic research organization to provide study management activities including randomization via Interactive Voice Recognition System (IVRS), site management, site monitoring, data management, statistical analysis, and oversight of safety processes including the Data Safety Management Board (DSMB) and the Clinical Events Committee (CEC).
Page 86 CLINICAL INCLUSION AND EXCLUSION CRITERIA Patients enrolled in PROTECT II were considered at high-risk for hemodynamic instability during non-emergent percutaneous coronary intervention due to a combination of depressed left ejection fraction and complex coronary lesions and deemed to require prophylactic hemodynamic support by the treating physician.
Page 87: Figure 6.1 Protect Ii Study Schematic
Explant as soon as patient deemed hemodynamically deemed hemodynamically stable stable 30-day follow-up or 30-day follow-up or discharge discharge 3 month follow-up 3 month follow-up Discharge patient from study Figure 6.1 PROTECT II Study Schematic Impella 5.5 ® with SmartAssist ® System...
Page 88: Accountability Of Protect Ii Cohort
ACCOUNTABILITY OF PROTECT II COHORT A total of 452 subjects were enrolled into the trial: 226 subjects enrolled in the Impella arm and ® 226 subjects enrolled in the IABP arm. This number represents 69% of the original planned enrollment (654 subjects). The PROTECT II trial was stopped prematurely by the company due to the Data Safety and Monitoring Board (DSMB) recommendation for futility after completing its pre-specified interim analysis at 50% enrollment for each group.
Page 89: Limitations Of Interpretation Of Study Results
LVEF. Of note, Impella patients presented more frequently with chronic heart failure (91.1% vs. 83.4%,) ® and had more often prior CABG (38.2% vs. 28.7%,) compared to IABP patients, respectively. Impella 5.5 ® with SmartAssist ® System...
Page 90 Table 6.2 Patient Baseline Characteristics (ITT Population) All Patients Impella Patients IABP Patients ® Patient Characteristics (N=448) (N=225) (N=223) Mean±SD (N) 67.3±10.8 (448) 67.7±10.8 (225) 67.0±10.7 (223) Range (Min, Max) (37,90) (40,90) (37,90) Gender - Male 80.4% (360/448) 79.6% (179/225) 81.2% (181/223) Ethnicity and Race Hispanic/Latino...
Page 91 STS Mortality and Morbidity Score Mean±SD (N) 29.52±15.34 (448) 28.80±14.97 (225) 30.24±15.71 (223) (1.60,74.50) (6.90,74.70) Range (Min, Max) (1.60,74.70) Logistic EuroScore Mean±SD (N) 18.39±17.44 (448) 18.76±17.41 (225) 18.03±17.49 (223) (1.33,91.15) Range (Min, Max) (0.82,94.53) (0.82,94.53) Impella 5.5 ® with SmartAssist ® System...
Page 92: Procedural Characteristics
PROCEDURAL CHARACTERISTICS In both study arms, more lesions were attempted than originally anticipated, as 27% of all patients had a lesion treated that was not identified as a target lesion in the pre-PCI revascularization treatment plan. The number of attempted lesions and deployed stents were similar between the two groups (Table 6.3).
Page 93 2.00 (2.00 - 8.00) (3.50 - 9.50) (2.00 - 4.00) Average number of passes per lesion when atherectomy was used Median (IQ Range) (1 - 4) (2 - 5) (1 - 2) 6.11 Impella 5.5 ® with SmartAssist ® System...
Page 94 Table 6.3 Procedural Characteristics (continued) All Patients Impella Patients IABP Patients ® (N=448) (N=225) (N=223) Average duration/run time per lesion when atherectomy was used (second) Median (IQ Range) 47.50 60.00 40.00 (32.50 - 85.00) (40.00 - 118.00) (20.00 - 47.00) Average number of stents placed when atherectomy was used Mean±SD (N) 3.44±1.61 (32)
Page 95: Safety And Effectiveness Results
® concerns as well. Abiomed formally terminated the study on December 6, 2010, at which point they unlocked all of the data (n=452) and performed additional analyses on the total cohort of patients enrolled into the PROTECT II study and available for analysis (n=448; 225 Impella subjects and 223 IABP ®...
Page 96 INTENT-TO-TREAT POPULATION At 69% of the planned enrollment, the 30-day MAE rate was 35.1% in the Impella ® compared to 40.1% in the IABP arm (Table 6.4a and Figure 6.3). The 90-day MAE rate showed trends in favor of Impella (40.6% vs.
Page 97: Figure 6.3 Kaplan-Meier Curves For Major Adverse Events (Intent-To-Treat Population)
Time after Initial Procedure (days) Impella Patients At Risk ® IABP Patients At Risk IABP Impella 2.5® Time post index procedure (days) Figure 6.4 Kaplan-Meier Curves for Major Adverse Events (Per-Protocol Population) 6.15 Impella 5.5 ® with SmartAssist ® System...
Page 98 PRE-SPECIFIED SUBGROUP ANALYSIS ON THE PRIMARY ENDPOINT Learning Curve The results of the pre-specified analysis without the Impella roll-in subject suggested the ® presence of a learning curve in the trial. Patients in the Impella arm, with the first subject ®...
Page 99 Relative ® Unprotected Left Main Patients Patients Difference Reduction or (PP) (N=49) (N=53) Increase 30 days or Discharge 38.8% 41.5% - 2.7% - 6.5% 90-day follow-up 41.7% 50.9% - 9.2% - 18% 6.17 Impella 5.5 ® with SmartAssist ® System...
Page 100 An analysis of the composite MAE for the subgroup whose indication for angioplasty was three- vessel disease is summarized in Tables 6.9a (ITT population) and 6.9b (PP population). The observed composite MAE rate was numerically lower for Impella vs. IABP at 30 and 90 days ®...
Page 101 3) the use of atherectomy appears to be ® potentially a confounding variable that may have affected the results of the trial (including the high STS group patient subgroup). 6.19 Impella 5.5 ® with SmartAssist ® System...
Page 102: Secondary Safety Results
SECONDARY SAFETY RESULTS The ten major adverse events components of the primary endpoint were analyzed separately, in both a non-hierarchical and hierarchical manner. Tables 6.12a and 6.12b summarize the individual major adverse events components in a non-hierarchical manner, in which all the MAEs for all the subjects are represented in the components.
Page 103 Increase in Aortic Insufficiency 0.0% 0.0% 0.0% 0.0% (0/216) (0/211) (0/215) (0/210) Severe Hypotension 10.2% 12.3% 10.2% 12.4% (22/216) (26/211) (22/215) (26/210) Angiographic Failure 3.7% 1.9% 3.7% 1.9% (8/216) (4/211) (8/215) (4/210) 6.21 Impella 5.5 ® with SmartAssist ® System...
Page 104: Secondary Effectiveness Results
SECONDARY EFFECTIVENESS RESULTS CARDIAC POWER OUTPUT (CPO) When measured by maximal drop in CPO from baseline, Impella appeared to provide better ® hemodynamic support compared to IABP (-0.04±0.24 vs. -0.14±0.27 Watts, respectively). CREATININE CLEARANCE The mean change in creatinine clearance from baseline to 24 hours post-procedure was equivalent for the two study arms: 4.64 ±...
Page 105: Summary Of Supplemental Clinical Information
- 21.1% PP (N=427) - 6% - 30.0% Relative MACCE at 90 Days Impella IABP Difference Reduction or ® Increase ITT (N=448) - 8% - 26.7% PP (N=427) - 9% - 29.4% 6.23 Impella 5.5 ® with SmartAssist ® System...
Page 106: Figure 6.5 Additional Analysis Of The Composite Mae And Macce Rates In The Per-Protocol Population Using A Meaningful, Contemporary Definition For Peri-Procedural Mi (8X Uln)
Time after Initial Time after Initial MACCE Procedure (days) Procedure (days) Impella Patients At Risk Impella Patients At Risk ® ® IABP Patients At Risk IABP Patients At Risk PP MAE Rates PP MACCE Rates IABP IABP Impella® Impella® Time After Initial Procedure (days) Time After Initial Procedure (days) Figure 6.5 Additional Analysis of the Composite MAE and MACCE Rates in the Per-Protocol Population Using a Meaningful, Contemporary Definition for Peri-Procedural MI (8x ULN)
Page 107: Figure 6.7 In-Hospital Mortality For "All Uspella Hrpci Patients," "All Uspella Hrpci Patients Who Met Protect Ii Criteria" And Protect Ii Patients For Both Iabp And Impella 2.5 Arm
USPELLA REGISTRY - IMPELLA 2.5 Abiomed opened a voluntary registry (USpella) for Impella use in the U.S. for all of its Impella ® devices, including the Impella 2.5 . Data is collected at all participating sites retrospectively ® without pre-selection of patients, and included high-risk PCI patients treated with the Impella 2.5 System (albeit from a broader high-risk PCI patient population than defined in the PROTECT II Study).
Page 108: Figure 6.8 Time Intervals For Impella Implants (Patient Selection) By Type Of Device
Mortality was similar between the USpella subsets and PROTECT II Impella 2.5 arm and IABP ® arm. This supports the observation in the PROTECT II trial (448 patient cohort) that there was no increased risk for mortality associated with the use of Impella and large bore access sheath ®...
Page 109 Hemodynamics were also measured. Baseline hemodynamics were similar for both cohorts. As expected, during support, both the Impella 2.5 and the Impella CP significantly increased the diastolic and the mean arterial blood pressures. 6.27 Impella 5.5 ® with SmartAssist ®...
Page 110 CLINICAL OUTCOMES COMPARISON The patient outcomes, as determined by the mortality and the site reported adverse events (AEs) were also analyzed. The results are provided in Table 6.14. Overall, there were no significant differences in adverse event rates between the patients supported with Impella CP and those supported with Impella 2.5.
Page 111: Figure 6.9 Kaplan-Meier Curve For Freedom From Death To 30-Days In Hrpci Patients Supported With Impella 2.5 Or Impella Cp
Impella CP patient deaths was determined to be related to the procedure. The patient had acute stent thrombosis causing ventricular fibrillation after the index procedure and required defibrillation, multiple rounds of cardiopulmonary resuscitation (CPR) and a salvage coronary intervention, and expired during the procedure. 6.29 Impella 5.5 ® with SmartAssist ® System...
Page 112: Table 6.16 Clinical Evidence To Support The Impella
Table 6.15 Causes of In-Hospital Deaths for HRPCI Patients Supported with Impella 2.5 or Impella CP ® in Impella Registry. Impella 2.5 Cause of Death Impella CP (N=72) (N=637) Myocardial Infarction 1.26% (8) 2.78% (2) Decompensated Heart/ Multi-Organ Failure 1.1% (7) Procedural Complication 0.31% (2) Respiratory Failure...
Page 113: Figure 6.10 Time Intervals For Impella Support (Patient Selection) By Type Of Device
Table 6.16). Details of the analyses of the datasets for the two LVEF cohorts, which were reviewed by the FDA, are provided below. Impella 2.5 Impella CP 2008 2012 May 2015 Figure 6.10 Time intervals for Impella Support (Patient Selection) by Type of Device 6.31 Impella 5.5 ® with SmartAssist ® System...
Page 114 Baseline Characteristics Comparison Patient demographics and baseline hemodynamic characteristics for the HRPCI patients supported with both devices were analyzed for both groups, as provided in Table 6.17. Patients with a baseline LVEF>35% were significantly older than patients with LVEF≤35% (72 ±11 years old vs.
Page 115: Table 6.17 Patient Demographics And Baseline Characteristics
30.19% (16/53) 0.270 Liver Insufficiency 2.28% (10/439) 2.74% (6/219) 0.717 COPD 25.28% (112/443) 28.96% (64/221) 0.312 Arrhythmia 36.50% (165/452) 27.85% (61/219) 0.026 30.82% (139/451) 26.24% (58/221) 0.221 64.63% (254/393) 31.98% (63/197) <.001 6.33 Impella 5.5 ® with SmartAssist ® System...
Page 116 Table 6.17 Patient Demographics and Baseline Characteristics (continued) Baseline Characteristics LVEF<=35% LVEF>35% (N=229 P-Value (N=464 Patients) Patients) NYHA Class 4.17% (8/192) 16.36% (9/55) 0.002 22.92% (44/192) 14.55% (8/55) 0.179 46.35% (89/192) 38.18% (21/55) 0.282 26.56% (51/192) 30.91% (17/55) 0.525 III/IV 72.92% (140/192) 69.09% (38/55) 0.577...
Page 117 1.58±2.93 (224) 0.018 ICU stay (days) Mean±SD(N) 5.27±5.24 (306) 3.90±4.08 (156) 0.002 Duration of Index Hospitalization (days) Mean±SD(N) 8.31±8.22 (464) 6.90±7.66 (229) 0.030 Pump Flow (L/min) Mean±SD(N) 2.27±1.06 (317) 2.14±0.43 (152) 0.075 6.35 Impella 5.5 ® with SmartAssist ® System...
Page 118 Table 6.18 Patient Admission, Procedural and Support characteristics (continued) Characteristics LVEF<=35% LVEF>35% (N=229 P-Value (N=464 Patients) Patients) 34.44% (478/1388) 33.29% (245/736) 0.595 Left Main 13.04% (181/1388) 23.37% (172/736) <.001 28.82% (400/1388) 28.26% (208/736) 0.787 19.09% (265/1388) 11.41% (84/736) <.001 Graft 4.61% (64/1388) 3.67% (27/736) 0.307...
Page 119: Table 6.19 In-Hospital Site-Reported Adverse Events
(93.9% in LVEF ≤35% cohort vs. 96.4% in LVEF>35% cohort). The mortality for patients who underwent Impella-supported PCI with LVEF>35 was 1.75% in-hospital and 3.6% at 30-day, lower than their STS predicted mortality. 6.37 Impella 5.5 ® with SmartAssist ®...
Page 120: Figure 6.11 Kaplan-Meier Curve For Freedom From Death To 30-Days In
Freedom from Death Days after device implantation LVEF<=35% (N=464 Patients) # Entered # Censored # At Risk # Events # Events per Month 55.7 38.6 31.4 23.0 % Survived 99.4% 96.8% 95.4% 94.2% 93.9% LVEF>35% (N=229 Patients) # Entered # Censored # At Risk # Events # Events per Month...
Page 121: Figure 6.12 Kaplan-Meier Curve For Freedom From Macce To 30-Days In
# At Risk # Events # Events per Month 30.0 19.3 17.1 13.0 % Free from MACCE 100.0% 96.4% 95.1% 93.2% 92.6% Figure 6.12 Kaplan-Meier Curve for Freedom from MACCE to 30-days in HRPCI 6.39 Impella 5.5 ® with SmartAssist ® System...
Page 122: Conclusion
Overall, the Impella Registry data analyses indicated that: • Patients undergoing high-risk PCI supported with both Impella devices in routine clinical practice, irrespective of their LVEF at the time of the intervention, are very sick, with high-risk features including complex and extensive coronary artery disease and multiple comorbidities, which would likely exclude them as surgical candidates.
Page 123: Clinical Experience Overview For Cardiogenic Shock After Acute Myocardial Infarction Or Open Heart Surgery
Signs of end-organ hypoperfusion OR Signs of left ventricular failure (Killip class 3 or Left Ventricular Ejection Fraction (LVEF)< 30% and Left Ventricular End-Diastolic Pressure (LVEDP)> 20 mmHg OR Cardiac Index (CI)< 2.2 l/min/m2 and Pulmonary Capillary Wedge Pressure (PCWP)> 15 mmHg 6.41 Impella 5.5 ® with SmartAssist ® System...
Page 124 Exclusion Criteria (Clinical Only) Age less than 18 years old Resuscitation for more than 30 minutes Obstructive, hypertrophic cardiomyopathy Marginal thrombus in the left ventricle Subjects with implanted IABP at the point in time of randomization Mechanical mitral and/or aortic valve, and/or severe valve stenosis Mechanical cause of cardiogenic shock Right ventricular failure Sepsis...
Page 125: Table 6.20 Baseline Demographics And Characteristics
Anterior myocardial infarction 50% (13) 54% (7) 46% (6) 1.000 (number) % Time from AMI to support device 9.9 ± 6.4 9.4 ± 6.6 10.4 ± 6.5 0.696 implant in hours (mean ± SD) 6.43 Impella 5.5 ® with SmartAssist ® System...
Page 126: Figure 6.13 Kaplan-Meier Survival Curves Survival (To 30-Days) For The Isar-Shock Trial
Table 6.21 Baseline Hemodynamics IABP Impella 2.5 Parameter p-value (mean ± SD) (mean ± SD) (mean ± SD) (n=25) (n=13) (n=12) Cardiac Index [l/min/m2] 1.8 ± 0.6 1.8 ± 0.8 1.7 ± 0.5 0.820 Heart rate [bpm] 96.8 ± 24.7 97.9 ±...
Page 127: Figure 6.14 Lactate Levels Seen Post-Implant During The Trial
Figure 6.15. In addition, after 24 hours of support, fewer patients supported with the Impella 2.5 required inotropes compared to patients supported with an IABP, as shown in Figure 6.16. 6.45 Impella 5.5 ® with SmartAssist ®...
Page 128: Figure 6.15 Increase In Cardiac Index From Baseline, Impella Vs. Iabp
Primary Endpoint: Increase in Cardiac Index From Baseline 0.75 P=0.02 0.60 0.45 0.30 0.49 0.15 0.11 Impella IABP Figure 6.15 Increase in Cardiac Index from Baseline, Impella vs. IABP 30 Minutes Post-Support, in Patients Treated for Cardiogenic Shock After an AMI (ISAR-SHOCK) Increase Same Decrease...
Page 129: Summary Of Supplemental Clinical Information
Impella 2.5, Impella CP, Impella 5.0 and Impella LD Support Systems. The registry, which was started by Abiomed in 2009, is open for participation by qualifying sites in the U.S. and Canada. Since the registry was started, to date a total of 59 sites have participated.
Page 130: Figure 6.17 Time Intervals For Impella Implants Data Collection By Type Of Device
Figure 6.17 Time Intervals for Impella Implants Data Collection by Type of Device Cases were initially identified using Abiomed’s commercial patient tracking system, and then further reviewed to verify that each case was applicable for this supplement (i.e. was an AMICS patient).
Page 131: Figure 6.18 Kaplan-Meier Curve Estimates For 30-Day Survival - All Patient Cohort
5.0/Impella LD, respectively. There was no observed difference in outcomes between the different devices, but a trend for better outcomes was seen for patients treated with Impella 5.0/ Impella LD (see Figure 6.19). 6.49 Impella 5.5 ® with SmartAssist ®...
Page 132: Figure 6.20 Outcomes Between Impella Registry Subgroups: Patients
ADDITIONAL ANALYSIS OF THE IMPELLA REGISTRY DATA An additional analysis of different subsets of the Impella Registry patients was provided. The analysis was completed to attempt to evaluate a potential benefit of Impella in a subgroup of the Impella Registry patients, which would be similar to patients selected in prior randomized AMICS RCTs.
Page 133: Figure 6.21 30-Day Outcomes (By Device) Between Impella Registry
Eligible for RCTs vs. Patients Likely to be Excluded from RCTs (“Salvage” Patients) Figure 6.22 Survival to Discharge Outcomes (By Device) Between Impella Registry Subgroups: Patients Likely to be Eligible for RCTs vs. Patients Likely to be Excluded From RCTs (“Salvage” Patients) 6.51 Impella 5.5 ® with SmartAssist ®...
Page 134: Figure 6.23 Kaplan-Meier Curve Estimates For 30-Day Survival
In order to provide a benchmark for the Impella devices in a comparable clinical setting (AMICS), Abiomed analyzed the results from its real-world registry for the AB5000 Ventricle. The AB5000 Ventricle was PMA approved (P900023/S038) in 2003 as a temporary VAD for use to treat AMICS.
Page 135: Figure 6.24 Survival To Discharge In Amics Cohort
Impella 5.0/Impella LD, this most likely due to more rigorous contemporary process of reporting adverse events, including all infections (urinary tract infections, streptococcus throat, etc.) in the Impella Registry. None of the infections was determined to be related to the device. 6.53 Impella 5.5 ® with SmartAssist ® System...
Page 136: Table 6.23 Site-Reported Adverse Events (To Discharge) By Classification
Table 6.23 Site-Reported Adverse Events (to Discharge) by Classification Impella 5.0/ AB5000/ Impella 2.5 Impella CP Adverse Events Impella LD BVS/AB p-value (n=189) (n=111) (n=24) (n=115) 55.03% 54.05% 50.00% ( 69.57% 0.036 Death (104/189) (60/111) 12/24) (80/115) 2.65% 3.60% 4.17% 21.74% <.001 CVA/Stroke...
Page 137 PCCS patients post device implant, as shown in Figure 6.25. In addition, concomitantly, as patients’ hemodynamics improved, a rapid and sustained weaning of inotropic and pressor support was also observed, as given Figure 6.26. 6.55 Impella 5.5 ® with SmartAssist ® System...
Page 138: Figure 6.25 Improvement In Patient Hemodynamics (From Baseline To 48Hrs Post Device Implant) For Recover I Patients
Figure 6.25 Improvement in Patient Hemodynamics (from Baseline to 48hrs Post Device Implant) for RECOVER I Patients Figure 6.26 Decrease in Inotropes and Pressors (Post-Device Placement) for RECOVER I Patients 6.56 Instructions for Use and Clinical Reference Manual (US)
Page 139 Impella to treat AMICS patients. The second component is a comparison of the results of the Impella literature review to a literature review of Abiomed’s PMA- approved surgical VADs (the BVS and AB5000) in AMICS. The third component is a literature review of the use of ECMO in this population, since ECMO is used as an alternative device to support these patients as well, albeit off-label.
Page 140: Cardiac Shock After Open Heart Surgery - Summary Of Primary Clinical Studies
CARDIAC SHOCK AFTER OPEN HEART SURGERY - SUMMARY OF PRIMARY CLINICAL STUDIES Clinical evidence was provided to support the overall safety and effectiveness of the Impella devices to treat the indications for use provided above. Specifically, the results of the RECOVER I study were provided as primary clinical evidence.
Page 141 Improved Hemodynamics– Post-device implant improvements in hemodynamics were to be demonstrated without additional adjunctive inotropic or vasoactive medications versus baseline • Device Placement and Technical Success • Time-to-Recovery • Reduction in Inotropic/Pressor Support 6.59 Impella 5.5 ® with SmartAssist ® System...
Page 142: Figure 6.27 Recover I Enrollment
ACCOUNTABILITY OF PMA COHORT The study enrolled 17 patients at 7 enrolling sites from October 18, 2006 to June 4, 2008. The overall enrollment for the RECOVER I trial is shown in Figure 6.27. Figure 6.27 RECOVER I Enrollment AMI: Acute Myocardial Infarction; CABG: Coronary Artery Bypass Grafting; FDA: Food and Drug Administration;...
Page 143: Table 6.25 Baseline Patient Hemodynamics
Mean±SD (N) 105.4±20.4 (16) [94.6, 116.3] Diastolic Arterial Pressure (mmHg) Mean±SD (N) 61.0±13.9 (16) [53.6, 68.4] Mean Arterial Pressure (mmHg) Mean±SD (N) 69.3±15.0 (13) [60.2, 78.4] PCWP (mmHg) Mean±SD (N) 14.0±. (1) 6.61 Impella 5.5 ® with SmartAssist ® System...
Page 144: Figure 6.28 Kaplan-Meier Survival Curve For Freedom From Death (To 1 Year)
Table 6.25 Baseline Patient Hemodynamics (continued) RECOVER I Patients Measurements [95% CI] (N=16) PA Systolic (mmHg) Mean±SD (N) 45.3±14.8 (16) [37.4, 53.2] PA Diastolic (mmHg) Mean±SD (N) 26.3±10.6 (16) [20.7, 32.0] Cardiac Index (l/min/m Mean±SD (N) 1.6±0.4 (12) [1.4, 1.9] CVP (mmHg) Mean±SD (N) 13.9±6.1 (15)
Page 145 This clinical study included 7 investigators. Neither of the clinical investigators had disclosable financial interests/arrangements as defined in sections 54.2(a), (b), (c), and (f). The information provided does not raise any questions about the reliability of the data. 6.63 Impella 5.5 ® with SmartAssist ® System...
Page 146: Summary Of Supplemental Clinical Information
Impella 2.5, Impella CP, Impella 5.0 and Impella LD Support Systems. The registry, which was started by Abiomed in 2009, is open for participation by qualifying sites in the U.S. and Canada. Since the registry was started, to date a total 59 sites have participated.
Page 147: Figure 6.30 Kaplan-Meier Curve Estimates For 30-Day Survival - All Patients Cohort
Cases were initially identified using Abiomed’s commercial patient tracking system. Using this method, seventy-seven (77) Impella cases were enrolled into the U.S. Impella Registry for this analysis. These included 19 Impella 2.5 cases, 14 Impella CP cases and 44 (combined) Impella 5.0 and Impella LD cases.
Page 148: Figure 6.32 Groups Used For Each Classification Analysis
In addition, analyses were completed using two different classification schemes. In one analysis, Classification A, the patients were categorized into three (3) different groups based on an incremental ascending risk for mortality, which were: (1) Post-cardiotomy Low Cardiac Output Syndrome (LCOS), (2) Post-cardiotomy Cardiogenic Shock (PCCS-CS) and (3) Post-cardiotomy Failure to Wean (PCCS-FW).
Page 149: Figure 6.34 Kaplan-Meier Curve For 30-Day Survival Using Classification A (Patients With Impella 5.0/Impella Ld)
Figure 6.34 Kaplan-Meier Curve for 30-day Survival Using Classification A (Patients with Impella 5.0/ Impella LD) Figure 6.35 Kaplan-Meier Curve for 30-day Survival Using Classification A (Patients with Impella CP) Figure 6.36 Kaplan-Meier Curve for 30-day Survival Using Classification A (Patients with Impella 2.5) 6.67 Impella 5.5 ® with SmartAssist ® System...
Page 150 For Classification B, the overall results (Kaplan-Meier curve estimates) for survival (to 30 days) for the patients are shown in Figure 6.37. Figures 6.38, 6.39 and 6.40 give the results for the different devices used. Using this classification, the trend suggest that patients with support prior to the procedure have better outcomes, which mirrors the results observed with Classification A Figure 6.37 Kaplan-Meier Curve for 30-day Survival Using Classification B (All Patients) Figure 6.38 Kaplan-Meier Curve for 30-day Survival Using Classification B (Patients with Impella 5.0/...
Page 151 In order to provide a benchmark for the Impella devices in a comparable clinical setting, Abiomed analyzed the results from its real-world registry for the AB5000 Ventricle. The AB5000 Ventricle was PMA approved (P900023/S038) in 2003 as a temporary VAD for use to treat PCCS.
Page 152 Figure 6.41 Flow Diagram of the Distribution of the AB5000 LVAD PCCS Patient Cohort The benchmark analysis included the overall survival to 30 days and to discharge in the PCCS. The 30-day Kaplan-Meier estimates are provided in Figure 6.42. For the survival to discharge, the Impella survival rate (50%) was statistically higher that the AB5000 survival (15%, p=0.002), as shown in Table 6.26.
Page 153: Table 6.26 Site-Reported Adverse Events (To Discharge) By Classification
Given the clinical presentation of these patients (all undergoing major cardiac surgery), similar bleeding and infection rates are expected. Overall, Abiomed’s benchmark analysis revealed that post-cardiotomy patients in the Impella Registry are comparable with the post-cardiotomy patients treated with the AB5000 device.
Page 154 HEMODYNAMIC EFFECTIVENESS RESULTS The Impella Catheters directly unload the left ventricle (LV) and propel blood forward, from the left ventricle into the aorta, in a manner most consistent with normal physiology. Impella provides both an active forward flow and systemic aortic pressure (AOP) contribution, leading to an effective increase in mean arterial pressure (MAP) and overall cardiac power output (CPO).
Page 155 Impella. Overall, the literature analysis provides further reasonable assurance of safety and effectiveness of the Impella devices in the proposed indications for use. 6.73 Impella 5.5 ® with SmartAssist ®...
Page 156: Impella Pccs Post-Approval Study (Pas)
IMPELLA PCCS POST-APPROVAL STUDY (PAS) SUMMARY OF THE POST-APPROVAL STUDY METHODS Study Objective The study objective was to monitor post-market approval safety and outcomes trends of the Impella Ventricular Support Systems in patients with post-cardiotomy cardiogenic shock (PCCS) who were implanted with an Impella device after approval of the PMA post-market study. Study Design The study was designed as an observational, prospective, multicenter, single cohort clinical investigation of patients with post-cardiotomy cardiogenic shock (PCCS) who were implanted...
Page 157 30%. As reported by the sites, the primary cause of death was cardiac related for 93% of the subjects, and most deaths (76%) were related to the patient’s prior condition. 6.75 Impella 5.5 ® with SmartAssist ®...
Page 158 Impella device, with no MACCE events (0/40) deemed “definitely” related to the Impella device. Three (3) device malfunctions were reported for two (2) subjects. Abiomed was unable to 6.76 Instructions for Use and Clinical Reference Manual (US)
Page 159 30 days, or discharge whichever is longer, and can be implanted with high degrees of device and technical success. The study size was limited with only sixty-three (63) patients enrolled. 6.77 Impella 5.5 ® with SmartAssist ®...
Page 160: Clinical Experience Overview For Cardiogenic Shock In The Setting Of Cardiomyopathy, Myocarditis, And Peripartum Cardiomyopathy
Impella 2.5, Impella CP, Impella 5.0, Impella LD and Impella RP Support Systems. The registry, which was started by ABIOMED in 2009, is open for participation by qualifying sites in the U.S., Canada and Europe. A total of 88 sites have participated in the registry since its initiation.
Page 161: Table 6.27 Demographics And Baseline Characteristics
15 (5 of 33) 13 (1 of 8) cardiomyopathy, % (N) Prior myocardial infarction, % 11% (10) 18 (9) 3 (1) 0 (0) Prior AICD/pacer, % (N) 33% (31) 54 (27) 9 (3) 11 (1) 6.79 Impella 5.5 ® with SmartAssist ® System...
Page 162: Table 6.28 Baseline Hemodynamics
Table 6.28 Baseline Hemodynamics Parameter All Subjects Cardio- Myocarditis Peripartum (N=93) myopathy (N=34) Cardiomyopathy (N=50) (N=9) Cardiac index (L/min/m2) 1.97 +/- 0.74 1.98 +/- 0.76 (20) 1.82 +/- 0.46 2.60 +/- 1.37 Mean +/- SD (N) (48) (23) Heart rate (bpm) Mean +/- 104.5 +/- 27.8 102.0 +/- 27.8 107.8 +/- 28.0...
Page 163 Impella support to another medical facility for escalation of care (N=3, 6%); 25 (50%) expired during index hospitalization (Figure 6.48A). Of the 22 patients discharged alive, 10 recovered their cardiac function, 9 received a durable VAD, and 3 received a heart transplant (Figure 6.48B). 6.81 Impella 5.5 ® with SmartAssist ® System...
Page 164 Figure 6.48 Survival to discharge (A) and patient status at discharge (B) – Cardiomyopathy patients (N=50) For the myocarditis patients, 21 patients were either discharged alive (N=16, 47%) or transferred on Impella support to another medical facility for escalation of care (N=5, 15%); 13 (38%) expired during index hospitalization (Figure 6.49A).
Page 165 Pulmonary capillary wedge pressure 23.5 +/- 7.3 18.7 +/- 6.7 0.02 (mmHg) (14) Mean +/- SD (N) Central venous pressure (mmHg) 24.6 +/- 6.2 19.5 +/- 10.4 0.34 Mean +/- SD (N) 6.83 Impella 5.5 ® with SmartAssist ® System...
Page 166: Table 6.31 Site-Reported Adverse Events (To Discharge)
IN-HOSPITAL ADVERSE EVENTS Site-reported in-hospital adverse events are shown in Table 6.31. There were no valve injuries or valve dysfunction adverse events reported. The major complications reported for the full cohort included cerebrovascular accident (4%), acute renal dysfunction (35%), acute hepatic failure (5%), hemolysis (13%), bleeding requiring transfusion (10%), anemia requiring transfusion (11%), infection (13%), limb ischemia (4%), vascular complication with (3%) or without (4%) surgery, respiratory dysfunction/failure (4%), and ventricular arrhythmia (9%).
Page 167: Table 6.32 Causes Of In-Hospital Death
AB5000 LVAD. While on LVAD support, the patient developed multiple complications and support was withdrawn upon the request from the patient’s family. This death was adjudicated as probably related to the LVAD implant procedure. 6.85 Impella 5.5 ® with SmartAssist ®...
Page 168 Table 6.33 In-Hospital Deaths CEC-Adjudicated as Related to the Device Deaths: CEC Device Definite Probable Possible Remote Not- Unknown Total Relatedness Related Cardiomyopathy Myocarditis PPCM Table 6.34 In-hospital Deaths CEC-Adjudicated as Related to the Procedure Deaths: CEC Device Definite Probable Possible Remote Not-...
Page 169 Figure 6.52 Kaplan-Meier curve estimates for 30-day survival – cardiomyopathy patients (N=50) Figure 6.53 Kaplan-Meier Curve Estimates for 30-day Survival – Myocarditis Patients (N=34) Figure 6.54 Kaplan-Meier Curve Estimates for 30-day survival – PPCM Patients (N=9) 6.87 Impella 5.5 ® with SmartAssist ®...
Page 170 SUMMARY OF THE IMPELLA REGISTRY DATA The Impella Registry data provides real-world perspective on the use of Impella devices in routine clinical practice in cardiomyopathy, myocarditis, and peripartum cardiomyopathy patients with ongoing cardiogenic shock. In spite of inherent limitations due to the retrospective nature of data collection, the Impella Registry data shows the following: •...
Page 171 The BVS/AB5000 review yielded only one publication, a retrospective, multi-center study using data collected in the ABIOMED voluntary registry, on 11 patients supported with the BVS 5000 for cardiogenic shock secondary to acute myocarditis. The BVS/AB5000 System is the only FDA-approved system for use in patients suffering from acute cardiac disorders such as viral myocarditis.
Page 172 In conclusion, for available data on both Impella in these populations and other devices (pulsatile VADs and ECMO) the survival rates are comparable to the survival rates reported in the USpella and cVAD Study analyses (Figure 6.55). In addition for those articles where AEs were reported, the USpella registry shows lower rates of morbidities associated with Impella than ECMO and surgical VADs.
Page 173: Impella Ami Cs Post-Approval Study (Recover Iii)
This summary includes data on qualifying subjects treated between April 7, 2016 (PMA approval date) and March 03, 2020. The date of database closure for the report was March 02, 2022 6.91 Impella 5.5 ® with SmartAssist ® System...
Page 174 Key Study Endpoints The primary study endpoint was survival at 30 days or discharge, whichever was longer. The secondary endpoint was the rate of site reported adverse events at 30 days or discharge, whichever was longer. Technical success and device (implant) success at exit from the catheterization laboratory or operating room was also evaluated.
Page 175: Table 6.36 Primary Endpoint - Survival At 30 Days Post-Implant Or Discharge, Whichever Is Longer
Subsequently the number of surviving subjects was decreased by 1 for each iteration, until the point is reached, at which the null hypothesis could no longer be rejected. Performance goal was 0.34. 6.93 Impella 5.5 ® with SmartAssist ®...
Page 176 Secondary Endpoint Site-reported adverse events at 30 days or discharge, whichever is longer served as the secondary endpoint. Across the total cohort, common adverse events included anemia requiring transfusion (25.91%), considered life-threatening, disabling or major, >= BARC 3a (13.80%), hemolysis (7.26%), acute renal dysfunction/failure (23.24%), infection in 14.53%, limb ischemia in 10.41%, and thrombocytopenia in 12.35% of patients.
Page 177: Clinical Experience For Systemic Anticoagulation Of Impella Patients Using Direct Thrombin Inhibitors
2.70% 1.43% CVA / Stroke 0.00% 0.67% 10.81% 4.29% Bleeding 1.72% 0.67% 13.51% 8.57% Thrombocytopenia 1.72% 1.00% 13.51% 4.29% Pulmonary embolism 0.00% 0.00% 0.00% 0.00% Deep vein thrombosis 0.00% 0.33% 0.00% 0.00% 6.95 Impella 5.5 ® with SmartAssist ® System...
Page 178: Patient Management Topics
Impella Catheter Outlet Area on or near Aortic Valve ........7.17 IMPELLA STOPPED ..................7.18 SUCTION ..................... 7.18 Suction with the Impella 5.5 with SmartAssist Catheter ........7.18 HEMOLYSIS ....................7.18 RESPONDING TO RISING IMPELLA MOTOR CURRENT .......7.20 ENABLING PURGE FLOW NOTIFICATIONS ..........7.20 DISABLING AUDIO ALARMS ...............7.20...
Page 179 PATIENT MANAGEMENT TOPICS (CONTINUED) OPERATING THE IMPELLA CATHETER IN ELECTROMAGNETIC FIELDS ..7.21 Electroanatomic Mapping (EAM) Systems ............7.21 Magnetic Navigation Systems (MNS) .............. 7.22 TRANSFERRING FROM THE AUTOMATED IMPELLA CONTROLLER TO A NEW AIC ....................7.23 Transfer Steps ....................7.23 Patient Management Checklist following Transfer of Support ......7.24 EMERGENCY SHUTDOWN PROCEDURE .............7.24 ANTI-COAGULATION THERAPY WITH IMPELLA HEPARIN INFUSION ..7.25 USE OF INTRA-AORTIC BALLOON PUMP WITH IMPELLA PATIENTS ..7.28...
Page 180: Patient Management Overview
Early shock identification and determining the etiology as cardiogenic are critical for initiation of appropriate therapy. Recognition of end-organ hypoperfusion in a patient with cardiac failure, through clinical assessment, laboratory testing (lactate, acidemia), and invasive testing with right heart catheterization enables diagnosis and tailored treatment planning. ® ® Impella 5.5 with SmartAssist System...
Page 181: Table 7.1 Clinical Society Guidelines For Impella Therapy
LITERATURE REVIEW: The Impella literature review encompasses a large body of scientific evidence from over 315 publications. The literature review provides further insight into the use of the Impella devices in routine clinical practice. The literature analysis shows that cardiogenic shock patients, who were treated with emergent hemodynamic support, are, in general, older and present with high-risk comorbidities, poor functional status, and depressed cardiac function.
Page 182: General Patient Care Considerations
• Pay close attention to all system components and connections when rolling the Automated Impella Controller cart over thresholds and through elevator doors. • Do not stress the connector cable from the controller to the Impella Catheter. ® ® Impella 5.5 with SmartAssist System...
Page 183: Right Heart Failure
RIGHT HEART FAILURE Caregivers should monitor patients being supported by the Impella Catheter for signs of right heart failure: • Reduced output from the Impella Catheter • Suction alarms • Elevated filling pressures (CVP) • Signs of liver failure • Elevated pulmonary pressures If the patient is exhibiting signs of right heart failure, the clinical team should assess the need for a more durable form of support.
Page 184 Impella Catheter is positioned correctly; however, these depictions are stylized and in actual echocardiograms inlet and outlet areas may not be seen as distinctly. The graphics in this section depict the Impella 5.5 with SmartAssist Catheter. Transesophageal Echocardiogram (TEE) of Impella Catheter Transthoracic Echocardiogram (TTE) of Impella Catheter Figure 7.1 Labeled TEE and TTE Images of the Impella Catheter Position...
Page 185 Four Impella Catheter positions you are likely to encounter when examining echocardiograms from patients supported with the Impella Catheter include: • Correct Impella Catheter position • Impella Catheter too far into the left ventricle • Impella Catheter inlet in the aorta •...
Page 186 The following figures depict transesophageal and transthoracic echocardiographic images of these four Impella Catheter positions. Figure 7.2 shows four transesophageal depictions of Impella Catheter position and Figure 7.3 shows four transthoracic depictions of Impella Catheter position. ® ® Impella 5.5 with SmartAssist System...
Page 187 a. Correct Impella Catheter Position (TEE) b. Impella Catheter Too Far into Left Ventricle (TEE) • Cannula bend should be at the aortic valve annulus, • Cannula bend inserted passed the aortic valve annulus placing inlet approximately 5 cm deep into ventricle. •...
Page 188 • Cannula bend inserted passed the aortic valve annulus or lodged between papillary muscle and the myocardial wall • Catheter outlet area too close to the aortic valve Figure 7.3 Transthoracic Echocardiographic (TTE) Illustrations of Impella Catheter Position ® ® Impella 5.5 with SmartAssist System...
Page 189 COLOR DOPPLER ECHOCARDIOGRAPHY When moving a patient supported with an Impella Catheter, it is important to monitor catheter migration. Adding color Doppler to an echo is another way to verify catheter position. If the Impella Catheter is correctly positioned, a dense mosaic pattern of turbulence will appear above the aortic valve near the outlet area of the catheter, as shown in the top image in Figure 7.4.
Page 190: Understanding And Managing Impella Catheter Position Alarms
Completing the steps shown in the following post-insertion positioning checklist can help to ensure proper position of the Impella 5.5 with SmartAssist Catheter following insertion. Pay particular attention to positioning after the patient is moved from the operating room or catheterization laboratory.
Page 191 Figure 7.5 for the Impella 5.5 with SmartAssist. Figure 7.5 Correct Impella 5.5 Catheter Position IMPELLA 5.5 WITH SMARTASSIST FULLY IN VENTRICLE If the Impella 5.5 with SmartAssist Catheter is fully in the ventricle, the following alarm will appear: Impella Position in Ventricle In this situation, the placement screen will appear as shown in Figure 7.6 below.
Page 192 Impella Catheter until the aortic waveform signal is showing. When you see the aortic waveform signal, pull the catheter back an additional 3 cm REPOSITIONING GUIDE FOR IMPELLA 5.5 WITH SMARTASSIST If fluoroscopy or other imaging guidance is not available and you receive an “Impella Position In Ventricle”...
Page 193 Figure 7.8 Pulling Catheter Back Until Waveform Shifts to Aortic Using the centimeter markings on the catheter, pull the Impella back slowly and additional 3 centimeters. Press the DONE soft button to continue. Figure 7.9 Pulling Catheter Additional 3 cm Release the anchor button to lock the Impella catheter in place.
Page 194 Figure 7.10 Locking the Catheter Anchor Press the DONE soft button to exit the repositioning guide. Ramp up slowly to the preferred P-level after exiting the guide. Figure 7.11 Repositioning Complete ® ® 7.15 Impella 5.5 with SmartAssist System...
Page 195 Impella 5.5 with SmartAssist Catheter raises the aortic blood pressure above the ventricular pressure during systole.
Page 196 Figure 7.13 Impella 5.5 with SmartAssist Catheter Position Unknown Actions to take: Assess cardiac function. If needed, confirm catheter position with echocardiography. IMPELLA CATHETER OUTLET AREA ON OR NEAR AORTIC VALVE If the Impella Catheter outlet area is on or near the aortic valve, the catheter may be too deep in ®...
Page 197: Impella Stopped
It may also be an indicator of right heart failure. SUCTION WITH THE IMPELLA 5.5 WITH SMARTASSIST CATHETER If the “Suction” alarm occurs during support with the Impella 5.5 with SmartAssist Catheter, follow the recommended actions: Reduce P-level by 1 or 2 levels to reduce the effects of suction.
Page 198: Table 7.2 Guide For Managing Hemolysis In Various Circumstances
Note on imaging: All imaging technology represents the anatomy in two dimensions (2D). It is not possible to assess the interactions between the catheter and the intraventricular anatomy that occur in three dimensions (3D). Abiomed strongly recommends that the catheter be repositioned, even if the imaging view shows correct position.
Page 199: Responding To Rising Impella Motor Current
Impella motor stopping. Table 7.3 Threshold motor currents Threshold Motor Current - Impella Will Stop Performance Level Impella 5.5 with SmartAssist 1030 1190 ENABLING PURGE FLOW NOTIFICATIONS The purge flow notification white alarms (“Purge Flow Increased” and “Purge Flow Decreased”) are disabled by default.
Page 200: Disabling Audio Alarms
Table 3.5. The Impella catheter has not been tested with any other anticoagulants, such as direct thrombin inhibitors, in the purge solution. Therefore, avoid the use of any alternative anticoagulants in the purge solution to prevent damage to the Impella catheter. ® ® 7.21 Impella 5.5 with SmartAssist System...
Page 201: Timed Data Recording
TIMED DATA RECORDING The Automated Impella Controller can hold up to 24 hours of real-time data. Once memory is full, the controller starts overwriting the old data. The timed data recording feature allows you to permanently save real-time operating data for later analysis. Timed data recording is automatically turned on during certain alarm conditions to capture data for analysis.
Page 202: Table 7.5 Troubleshooting When Operating The Impella Catheter In The Presence Of A Mns System
Displayed flow seems too high when the MNS magnets are in the “Navigate” position. The displayed flow will be accurate when the MNS magnets are in the “Stowed” position. MNS magnets: “Stowed” Displayed flow drops ® ® 7.23 Impella 5.5 with SmartAssist System...
Page 203: Transferring From The Automated Impella Controller To A New Aic
After transferring patient support to or from the Automated Impella Controller, perform each of Questions or Concerns? the following patient management checklist items: Contact the local Abiomed team or call the 24 hour Confirm Impella Catheter placement using echocardiography. clinical support line at Confirm the anchor is secure on the Impella Catheter to prevent catheter migration.
Page 204: Anti-Coagulation Therapy With Impella Heparin Infusion
As a result, when heparin is used in the purge fluid, the heparin infused via the Impella purge system needs to be accounted for in institutional protocols, which include heparin for systemic anti-coagulation. Abiomed’s recommendation on an optimal method to include Impella heparin infusion into an anti-coagulation protocol is provided below.
Page 205: Table 7.6 Clinical Scenarios For Anti-Coagulation Therapy With The Impella Purge System Heparin (50 U/Ml)
Table 7.6 Clinical scenarios for anti-coagulation therapy with the Impella purge system heparin (50 U/ml). Scenario #1 – Total heparin = 8 U/kg/hour; IV Heparin Concentration = 100 U/mL Patient Weight (kg) Impella Purge^ Flow (mL/hour) IV Heparin (mL/hour) -1.5† -4†...
Page 206: Table 7.7 Patient Scenarios For Anti-Coagulation Therapy With The Impella Purge System Heparin (25 U/Ml)
Scenario #2 - Total heparin = 10 U/kg/hour; IV Heparin Concentration = 100 U/mL Patient Weight (kg) Impella Purge^ Flow (mL/hour) IV Heparin (mL/hour) † Impella purge heparin = 25 U/mL Please contact Abiomed’s Clinical Support Center, 1-800-422-8666, if you have questions. ® ® 7.27 Impella 5.5...
Page 207: Use Of Intra-Aortic Balloon Pump With Impella Patients
USE OF INTRA-AORTIC BALLOON PUMP WITH IMPELLA PATIENTS Simultaneous use of an intra-aortic balloon pump (IABP) and an Impella device may result in lower than expected Impella flow, and may cause Impella position alarms, Impella suction alarms, and hemolysis. Prolonged simultaneous use of an IABP and Impella is not recommended.
Page 208 Page intentionally left blank. ® ® 7.29 Impella 5.5 with SmartAssist System...
Page 209: Automated Impella Controller Alarms
8 AUTOMATED IMPELLA CONTROLLER ™ ALARMS ALARMS OVERVIEW ..................8.1 Alarm Levels ....................8.1 Alarm Display ....................8.2 Mute Alarm Function ..................8.2 Alarm History Screen ..................8.2 ALARM MESSAGE SUMMARY ..............8.3...
Page 210: Alarms Overview
For some alarms, there is a short delay between the triggered event and the audible annunciation and visual display of the alarm. (For more information, refer to the “Alarm Delay Information” discussion in section 9 of this manual.) ® ® Impella 5.5 with SmartAssist System...
Page 211 Controller is powered down or after a power failure. The controller also maintains a long-term log that is saved after the Automated Impella Controller is powered down or after a power failure and this information may be downloaded by Abiomed personnel. Instructions for Use and Clinical Reference Manual (US)
Page 212: Alarm Message Summary
3. Return to preferred P-level and confirm positioning with imaging. To prevent retrograde flow, restart Impella Catheter is not running; possible Impella Stopped Impella or withdraw pump from retrograde flow through Impella Catheter. Retrograde Flow ventricle. ® ® Impella 5.5 with SmartAssist System...
Page 213 Table 8.2 Automated Impella Controller Alarm Messages (continued) Severity Alarm Header Action Cause Impella Stopped 1. Restart Impella. There may be a mechanical or electrical problem in the Impella Catheter. 2. Replace Impella after 3rd unsuccessful restart attempt. Impella Stopped 1.
Page 214 Bag. 1. Replace Impella with supported catheter. The Impella Catheter is not supported to operate Impella Catheter Not with the current version of controller software 2. Contact Abiomed Service to upgrade Impella Supported and/or hardware. Controller. Do not use Impella.
Page 215 Placement Monitoring enable Placement Monitoring under MENU and User has disabled Placement Monitoring. Disabled Settings/Service. Purge Cassette Contact Abiomed Service to update Impella Incompatible purge cassette RFID version. Incompatible Controller. The purge flow has decreased by Purge flow has decreased by 2.5 mL/hr or more.
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Page 217: General System Information
PATIENT ENVIRONMENT ................9.14 USE ENVIRONMENT..................9.14 IMPELLA CATHETER PARAMETERS ............9.15 TECHNICAL SPECIFICATIONS ..............9.16 IMPELLA 5.5 WITH SMARTASSIST CATHETER DIMENSIONS...... 9.16 CLEANING ....................9.17 STORING THE AUTOMATED IMPELLA CONTROLLER ........9.17 RETURNING AN IMPELLA CATHETER TO ABIOMED (UNITED STATES) ..................9.17...
Page 218: Terminology, Abbreviations, And Symbols
Declares conformity with Directive 93/42/EEC for medical devices, and with Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment Date of manufacture (e.g., October 1, 2014) 2014-10-01 ® ® Impella 5.5 with SmartAssist System...
Page 219 Table 9.2 Symbols (continued) Protect from sunlight Symbol for lot designation; the manufacturer’s lot designation must be stated after the LOT symbol Abiomed part number (e.g., part number 123456) REF 123456 Manufacturer’s serial number (e.g., serial number 123456) SN 123456...
Page 220: Automated Impella Controller Mechanical Specifications
14.3 kg (31.5 lbs) Maintenance and 12 months repair interval (Work must be performed by technicians authorized by Abiomed who have completed Abiomed’s Service Training Certification Program) AUTOMATED IMPELLA CONTROLLER ELECTRICAL SPECIFICATIONS Table 9.4 Electrical Specifications for the Automated Impella Controller 100-240 V AC;...
Page 221: Equipment Design
EQUIPMENT DESIGN The Automated Impella Controller conforms to the applicable requirements of the following standards: • IEC 60601-1: 2012 Edition 3.1 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance CSA C22.2#60601-1 (2014) Ed:3 Medical Electrical Equipment Part 1: General •...
Page 222: Federal Communications Commission (Fcc) Notice
Use of cables, other than those sold by Abiomed, may result in increased emissions or decreased immunity of the Automated Impella Controller.
Page 223: Use Of Extracorporeal Membrane Oxygenation (Ecmo) With Impella Patients In Cardiogenic Shock
USE OF EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WITH IMPELLA PATIENTS IN CARDIOGENIC SHOCK If the use of Extra-corporeal Membrane Oxygenation (ECMO) is to be initiated in a cardiogenic shock patient currently being treated with Impella, the benefits and risks of continuing Impella therapy for left ventricle unloading during ECMO support should be considered.
Page 224: Transport Between Hospitals
AC power inverter. IMPORTANT TRANSPORT CONSIDERATIONS Planning is critical to success. Abiomed representatives can help with planning for transport. They can be contacted 24 hours a day at 1-800-422-8666. The Automated Impella Controller should be fully charged prior to transport. Keep the Automated Impella Controller connected to AC power (or an AC inverter) whenever possible.
Page 225: Specifications For Grounding Cable
GROUND THE AUTOMATED IMPELLA CONTROLLER FOR AIR TRANSPORT If the patient is being transported by helicopter or fixed-wing aircraft, the Automated Impella Controller should be grounded using a cable with the specifications below. Connect the cable to the Automated Impella Controller’s equipotential ground stud (see Figure 4.2) and the aircraft’s chassis ground.
Page 226 CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment. ® ® Impella 5.5 with SmartAssist System...
Page 227 Table 9.8 Guidance and Manufacturer’s Declaration - Immunity The Automated Impella Controller is intended for use in the electromagnetic environment specified below. The customer or user of the Automated Impella Controller should ensure that it is used in such an environment. IEC 60601 Compliance Electromagnetic Environment –...
Page 228 NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. ® ® Impella 5.5 with SmartAssist System 9.11...
Page 229 Table 9.11 Testing for immunity to portable and mobile RF transmitters, for which the recommended separation distance is 30 cm (12 inches) Test Band Service Compliance frequency level (MHz) (MHz) (V/m) 380 - 390 TETRA 400 430 - 470 GMRS 460, FRS 460 704 - 787 LTE Band 13, 17 GSM 800/900, TETRA 800, iDEN 820, CDMA 850,...
Page 230: Vga Monitor Connection
Automated Impella Controller operating parameters are not affected. Do not insert any unauthorized devices into the USB port. This includes chargers, memory sticks, wireless dongles and other unauthorized devices. ® ® Impella 5.5 with SmartAssist System 9.13...
Page 231: Alarm Delay Information
ALARM DELAY INFORMATION For some Automated Impella Controller alarms, there is a short delay between the triggered event and the audible annunciation and visual display of the alarm. Table 9.14 Alarm Delay Information 8 second delay Impella Defective 11±5 second delay Impella Position Wrong 12±3 second delay Controller Error...
Page 232: Impella Catheter Parameters
IMPELLA CATHETER PARAMETERS Table 9.15 Impella 5.5 with SmartAssist Catheter Parameters 0 to 33,000 rpm Speed Range Less than 16 W Power Consumption Max. 20 V DC Voltage 5.5 L/min Flow-Maximum Purging the Impella 5.5 Catheter 5% dextrose solution with heparin (25 or 50 IU per mL)
Page 233: Technical Specifications
0.2 Watts *the measured root mean square error (of multiple measurements) Metric accuracy determined in vitro. Data on file at Abiomed, available upon request. IMPELLA 5.5 WITH SMARTASSIST CATHETER DIMENSIONS Figure 9.2 Impella 5.5 with SmartAssist Catheter Dimensions 70 cm 20.5 - 45.5 cm...
Page 234: Cleaning
RETURNING AN IMPELLA CATHETER TO ABIOMED (UNITED STATES) To return an Impella Catheter to Abiomed, contact your local Clinical Consultant for an Abiomed- approved return kit.* The kit includes instructions for returning the Impella Catheter to Abiomed. * Only available in the United States ®...
Page 235: Appendices
APPENDICES APPENDIX A: IMPELLA VENTRICULAR SUPPORT SYSTEMS LIMITED SERVICE WARRANTY (UNITED STATES) ....... A.1 APPENDIX B: AUTOMATED IMPELLA CONTROLLER MENU STRUCTURE ..B.1 Overview ......................B.1 Mute Alarm ..................... B.1 Flow Control ....................B.1 Display ......................B.2 Purge Menu .....................B.2 Menu ......................B.3...
Page 236: Appendix A: Impella Ventricular Support Systems Limited Service Warranty (United States)
Goods will become the property of Abiomed. This warranty shall not apply if the Goods have been: (a) repaired or altered in any way by other than Abiomed or Abiomed authorized service personnel; (b) subjected to physical or electrical abuse or misuse;...
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Page 238: Appendix B: Automated Impella Controller Menu Structure
The FLOW CONTROL soft button opens the FLOW CONTROL menus. Before the Impella Catheter is started, the menu options include OFF and Start Pump. For the Impella 5.5 with SmartAssist, Menu options include P-levels between P-0 and P-9 as shown in section 5 in this manual.
Page 239 DISPLAY The DISPLAY soft button opens a menu that includes the following options for viewing waveforms and navigating to other screen displays: • Y-axis Scale – opens a menu from which you can select a waveform and change its appearance by adjusting the scale of the y-axis. Once the waveform is selected, turn the selector knob clockwise to increase the y-axis scale and counterclockwise to decrease the y-axis scale.
Page 240 Mean Arterial Pressure. Optical Bench Service - When no pump is connected, this display appears for console information. Used by Abiomed personnel only. Screen Brightness. Opens the Screen Brightness selection box. The brightness of the screen display can be set from 50% to 100%.
Page 241 Disable (Enable) Retrograde Flow Control. If the Impella Catheter minimum flow is below 0.1 L/min then the controller will increase the motor speed to prevent retrograde flow. This menu selection can be used to disable Retrograde Flow Control during weaning. This selection is available whenever the Impella Catheter is connected. Enable (Disable) Purge Flow Change Notification.
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Page 243 Clinical support 24 hours per day, 7 days a week: 1-800-422-8666 (US) 00800 0 22 466 33 (EU) www.abiomed.com Abiomed, Inc. Abiomed Europe GmbH 22 Cherry Hill Drive Neuenhofer Weg 3 Danvers, Massachusetts 01923 USA 52074 Aachen, Germany Voice: 978-646-1400...

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