TransMedics OCS Lung System Clinical User Manual
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TransMedics OCS Lung System Clinical User Manual

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TransMedics
Organ Care System
Clinical User Guide: OCS
™
Lung System
Software Version 3.1.2
PN 100004071 Rev 5
REF 2102
0086
© 2018 by TransMedics, Inc. All rights reserved. Printed in U.S.A.
PN 100004071, Rev 5
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  • Page 1 ® ™ TransMedics Organ Care System Clinical User Guide: OCS ™ Lung System Software Version 3.1.2 PN 100004071 Rev 5 REF 2102 0086 © 2018 by TransMedics, Inc. All rights reserved. Printed in U.S.A. PN 100004071, Rev 5 Page 1...
  • Page 2 TransMedics Legal Department. This document is intended to be used by customers and is licensed to them as part of their TransMedics equipment purchase. Use of this document by unauthorized persons is strictly prohibited.

  • Page 3: Table Of Contents

    Warnings and Precautions ..................10 1.7. Conventions ......................10 1.8. Supplies ......................... 11 1.9. Contacting TransMedics ..................11 CHAPTER 2: OVERVIEW OF OCS™ LUNG SYSTEM ........... 12 2.1. System Components ..................... 12 2.2. Overview of OCS™ Lung System Preservation Process ........12 2.3.
  • Page 4 Table of Contents 6.1. Final Recruitment in Preservation Mode ..............52 6.2. Final Monitoring/Overview ..................52 6.3. Implantation Decision .................... 55 6.4. Lung Preservation Termination ................55 6.5. Performing the Shut-Down Protocol ..............60 6.6. Preparing the OCS™ Lung System for Shutdown ..........60 6.7.

  • Page 5: List Of Symbols In This Guide

    List of Symbols LIST OF SYMBOLS IN THIS GUIDE Symbol Meaning Run/Standby button on Wireless Monitor Wireless Bluetooth link between the Wireless Monitor and the OCS ™ Lung Console ON position for OCS ™ Lung Console Pause Preservation mode icon on the Wireless Monitor screen Preservation mode icon on the Wireless Monitor screen Continuous Monitoring mode icon on the Wireless Monitor screen Bronchoscope Monitoring mode icon on the Wireless Monitor screen...

  • Page 6: Glossary Of Terms

    Glossary of Terms GLOSSARY OF TERMS Term Meaning Arterial Blood Gas Breaths/minute Bronchoscope Ventilation of the lungs with ambient air, to allow endoscopic examination of lung’s airways Mode Bronchoscope Port on the Lung Perfusion Module through which a Bronchoscope probe may be inserted to inspect Port the interior of the lung Circuit...
  • Page 7 Glossary of Terms Term Meaning Pause A Ventilator mode in which the bellows remain stationary and the OCS™ Lung System achieves a Preservation static level of lung inflation. Pause Preservation enables oxygenation of perfusate prior to lung Mode instrumentation using the Lung Preservation Gas. Peak Air Way Pressure.
  • Page 8 Glossary of Terms Term Meaning Oxygen saturation of venous (deoxygenated) perfusate, expressed as a percentage and measured at the inflow to the lung on the PA line /Hematocrit An OCS™ Lung System probe that you attach to the Lung Perfusion Module. It is used to measure Probe the venous oxygen saturation and hematocrit of the perfusate entering the lung through the pulmonary artery cannula.

  • Page 9: Chapter 1: Read This First

    Wireless Monitor controls and functions, see the TransMedics Technical User Guide: OCS™ Lung System. Both guides are to be reviewed prior to using the system, noting the Warnings and Cautions throughout the guides.

  • Page 10: Warnings And Precautions

    Conventions The system, OCS™ Lung System, the lung system, and OCS™ are used interchangeably throughout ™ this manual to refer to the TransMedics OCS Lung System. The system uses consistent conventions throughout the interface and accompanying documentation to make it easy for you to learn and use.

  • Page 11: Supplies

    Lung System must be used in accordance with this user manual, associated documents, and accepted medical standards. CAUTION— Only accessories and supplies purchased from or recommended by TransMedics, Inc. are to be used with the TransMedics OCS ™ Lung System. Use of accessories and supplies other than those supplied by or recommended by TransMedics may cause system malfunction and invalidate the TransMedics warranty.

  • Page 12: Chapter 2: Overview Of Ocs™ Lung System

    Chapter 2: Overview of OCS™ Lung System CHAPTER 2: OVERVIEW OF OCS™ LUNG SYSTEM The TransMedics® Organ Care System (OCS™) Lung System is a portable organ perfusion, ventilation and monitoring medical device intended to preserve donated lungs in a near physiologic, ventilated, and perfused state for transplantation.

  • Page 13: Clinical Study Of The Ocs ™ Lung System

    A summary of the study and the results are provided in Appendix A of this document. NOTE— It is essential that you carefully review the study results in Appendix A: OCS ™ Lung System INSPIRE Study. If you have any questions about these results, please contact TransMedics. PN 100004071, Rev 5 Page 13...

  • Page 14: Chapter 3: Activities Performed Before Departure To Donor Site

    Chapter 3: Activities Performed Before Departure to Donor Site CHAPTER 3: ACTIVITIES PERFORMED BEFORE DEPARTURE TO DONOR SITE Adequate preparation ensures the smoothest possible organ retrieval run with the OCS™ Lung System. This chapter provides information on the checklists and tasks that are performed at the recipient site prior departure to the donor site.

  • Page 15: Checklists For Ocs™ Lung Gas Cylinders

    — NOTE For more information, see “Estimating the Remaining Preservation Gas Supply” in the TransMedics Technical User Guide: OCS™ Lung System. Replace the cylinder if necessary. Close the gas valve after check and after use. 3.2.2.

  • Page 16: Ocs™ Lung Solution & Additives Checklists

    Chapter 3: Activities Performed Before Departure to Donor Site Lung Monitoring Gas Cylinder checklist: 1. Ensure the Lung Monitoring cylinder is ≥ 50% full (At least 1500 psi) before departure to donor site. Otherwise, replace or take a spare. 2. Regulator and green line (Monitoring Regulator Kit) are attached to the cylinder before usage. ™...
  • Page 17 Chapter 3: Activities Performed Before Departure to Donor Site *Use 10 mEq of NaHCO or 1 mmol of THAM/L (tromethamine) to buffer the OCS Lung Solution immediately before usage. 3.3.2. OCS™ Lung Perfusate & Additives • 1.5-2 L of buffered* OCS™ Lung Solution is the only recommended solution for priming the LPM in preparation for Lung perfusion on the OCS Lung System * Use 10 mEq of NaHCO...

  • Page 18: Leukocyte Reduced Packed Red Blood Cells (Prbcs) Checklist

    Lung System to Run Mode and verify that the lung system passes the Self Test. a. If displayed errors indicate problems, refer to the Troubleshooting chapter in the TransMedics Technical User Guide: OCS ™ Lung System. 7. If no errors display, select “New Session File” and confirm the following: a.

  • Page 19: Run Bag Checklist And Contents

    Chapter 3: Activities Performed Before Departure to Donor Site b. NO (+++) OR (- - -) values are displayed on the Monitor for Pulmonary Artery Pressure (PAP) or the airway pressure readings. WARNING— Abnormal values of either (+++) or (- - -) displayed on the Wireless Monitor as Mean PAP or if airway pressure measurements indicate readings above or below (respectively) preset ranges as read by the sensors in the installed LPM.
  • Page 20 8. Remember to take the Mobile Base with you for use at the donor site. For additional information on safely transporting the OCS™ Lung System, including temperature and humidity limits, see the TransMedics Technical User Guide: OCS™ Lung System. Figure 3.2: Lifting the OCS™...

  • Page 21: Chapter 4: Activities Performed At Donor Site

    Unpacking and Inspecting the Lung Perfusion Set (LPS) Accessories packaged and shipped with the LPS should be unpacked immediately before use. For illustrations and descriptions of the components included in the LPS, see the TransMedics Technical User Guide: OCS™ Lung System.

  • Page 22: Installing The Lpm On The Ocs ™ Lung System

    Do not uninstall the LPM while the Pump or Ventilator is ON as doing so may cause the Pump or Ventilator to jam. If this occurs, reset the system as described in the TransMedics Technical User Guide: OCS™ Lung System.
  • Page 23 Chapter 4: Activities Performed at Donor Site Figure 4.2: Pump Head, Ventilator Actuator of the OCS ™ Lung Console (A) and the Bellows Plate of the LPM (B) ™ 6. Push the LPM backwards after ensuring proper alignment of the OCS Lung System holding clips with the LPM’s recesses to keep it in place.
  • Page 24 Chapter 4: Activities Performed at Donor Site Figure 4.4: Ventilator Lines Connection Port WARNING— When connecting the Ventilator lines, ensure that the recessed notch on the LPM Ventilator lines connector aligns with the corresponding raised tab on the OCS™ Lung Console Ventilator lines connection port in the Lung Console (Figure 4.4).

  • Page 25: Attaching The Probes

    Chapter 4: Activities Performed at Donor Site 10. Close the pulmonary artery flush port as seen in Figure 4.7. Figure 4.7: Closing the PA Flush Port 4.3. Attaching the Probes This section provides detailed instructions on attaching the Pump flow probe, the SaO /Hematocrit probe, and the SvO /Hematocrit sensor/probe to the tubing on the LPM.
  • Page 26 Chapter 4: Activities Performed at Donor Site Figure 4.8: Pump Flow Position 4.3.2. Attaching the SaO /Hematocrit and SvO /Hematocrit Probes The SaO /Hematocrit and SvO /Hematocrit optical probes are designed to be clipped onto cuvettes that are incorporated into the LPM’s tubing. The cuvette is marked with colored bands at each end. The color of the bands should match the color of the label on the corresponding probe.

  • Page 27: Running The Ocs ™ Lung System Self Test

    If the system detects an issue during the Self Test, a message is displayed with information about the issue until it is resolved. To resolve the issue, follow the steps in the troubleshooting section of the TransMedics Technical User Guide: OCS™ Lung System.

  • Page 28: Preparing The Ocs™ Lung System For Lung Instrumentation

    At the beginning of the session, the system may display messages and sound alarms related to sensor probes. These messages and alarms can be disregarded. For details of system initialization and messages, see the TransMedics Technical User Guide: OCS™ Lung System.
  • Page 29 Chapter 4: Activities Performed at Donor Site Table 4.1: Priming Overview Settings ™ Lung System Recommendations Priming • 1.5-2 L of buffered* OCS ™ Lung Solution • +3 units of pRBCs • Medications (additives & prophylactic medications) *Use 10 mEq of NaHCO or 1 mmol of THAM/L (tromethamine) to buffer the Lung Solution immediately before usage.
  • Page 30 Chapter 4: Activities Performed at Donor Site 8. Clamp and cover the Priming Inlet Port of the LPM with one of the provided spare covers on the modules. Reposition the covered Priming Inlet Port back in its recess. 9. Turn on the Pump to start circulating, mixing, and warming the perfusate. Figure 4.12: LPM Priming Inlet Port 4.5.4.
  • Page 31 Confirm that the OCS™ Lung System defaults to Pause Preservation Mode on the Wireless Monitor. e. If Pause Preservation Mode was not configured, please refer to the TransMedics Technical User Guide: OCS™ Lung System. f. Ensure that the PA stopcock (blue) stays open as seen in Figure 4.13 to de-air the PA flow.
  • Page 32 Chapter 4: Activities Performed at Donor Site Recommended Additives Recommended Dosage Sodium Bicarbonate (NaHCO 40 mEq Cefazolin (or equivalent gram positive antibiotics) Ciprofloxacin (or equivalent gram negative antibiotics) 200 mg Voriconazole or Caspofungin (or equivalent antimycotic) 200 mg 70 mg (for Caspofungin) To inject additives into the perfusate: 1.

  • Page 33: Harvesting Donor Lungs

    Evaluating Hematocrit and Reservoir Volume Level After components of the perfusate have been added to the reservoir and have been circulating for approximately 2-3 minutes during priming, evaluate the HCT. TransMedics recommends the perfusate’s HCT to be between 15-25% for optimal lung evaluation.
  • Page 34 A sterile operator performs back-table lung preparation while a non-sterile operator primes and prepares the lung system for instrumenting the lungs. 4.6.4. Securing TransMedics® Cannulae to the Donor Lung These procedures require supplies from the Lung Instrumentation Tool Set. You will need to supply and use the following: •...
  • Page 35 3. Select the appropriate size trachea cannula, insert the largest cannula that fits into the trachea, and connect it by using the TransMedics cable ties (1 or 2 ties) and cable tie tool (Figure 4.16). 4. Clamp the flexible portion of the trachea cannula with the TransMedics tubing clamp.
  • Page 36 Chapter 4: Activities Performed at Donor Site Figure 4.17: PA Cannula Alignment 3. Position cannula tip in the main PA to ensure equal and homogeneous perfusion to both lungs (Figure 4.18). Figure 4.18: PA Cannula Tip Positioning 4. Secure the cannula using a silk tie or a purse string suture and a silk tie above the ridge at the tip of the PA Cannula.

  • Page 37: Draping The Work Area In Preparation For Instrumentation

    Chapter 4: Activities Performed at Donor Site Figure 4.19: Reconstructed PA 4.7. Draping the Work Area in Preparation for Instrumentation As the PA and trachea are being cannulated and after taking the priming blood sample from the perfusate, drape the lung system in preparation for instrumenting the lungs by a sterile surgeon. Steps: 1.

  • Page 38: Instrumenting Lungs On The Ocs™ Lung System

    Chapter 4: Activities Performed at Donor Site If the Wireless Monitor is to be left in its docking cradle during lung instrumentation: • Assure that the clear film covers the Wireless Monitor so that the controls and screen can be easily seen and accessed by the user. •...
  • Page 39 Chapter 4: Activities Performed at Donor Site 4.8.2. Instrumentation Sequence Overview Figure 4.21 illustrates the sequence of instrumentation. Figure 4.21: Sequence of Instrumentation 4.8.3. Connecting Trachea Cannula and PA Cannula to OCS™ Lung System 1. Connect the Trachea Cannula to the Lung Organ Chamber’s Trachea Connector. 2.
  • Page 40 Chapter 4: Activities Performed at Donor Site 4.8.4. Initial Stabilization Overview Table 4.4 provides recommended settings for initial stabilization. Table 4.4: Initial Stabilization Settings ™ Settings Lung System Preservation Settings • Reset to 37°C in Preservation settings Instrumentation Temperature Pump Flow •...
  • Page 41 Chapter 4: Activities Performed at Donor Site While gradually warming the lungs, press the main Configuration menu button and set the ventilation settings to match settings in Table 4.4 under both Preservation and Monitoring Menu tabs (if not performed during priming). 4.8.6.
  • Page 42 Chapter 4: Activities Performed at Donor Site 4.8.9. Steps of Lung Wrapping Figure 4.22 illustrates the steps for applying the OCS ™ Lung Wrap. Figure 4.22: Steps of Lung Wrapping 1. Approximate both lungs to mid line (Anatomical position). 2. Wrap both lungs with one fold of the OCS ™...
  • Page 43 Chapter 4: Activities Performed at Donor Site 4.8.10. Applying Banded Bags/Sterile Covers Apply two sterile banded bags to a closed Lung Organ Chamber prior leaving the donor’s OR to provide additional protection to the organ from external environmental contamination during transport.

  • Page 44: Initial (Baseline) Monitoring Overview

    Chapter 4: Activities Performed at Donor Site • PEEP and TV are fully delivered and maintained in Preservation Mode Figure 4.23: Applying the Sterile Covers/Banded Bags CAUTION— Do not disconnect the OCS™ Lung System from AC power until you are ready to leave the donor site. 4.9.

  • Page 45: Continuous Monitoring Mode

    Chapter 4: Activities Performed at Donor Site 4.9.2. Continuous Monitoring Mode Timing and Settings PA (Pump) Flow Recommendation for Continuous Monitoring Mode: • 2-3 L/min WARNING— For mildly injured or hemorrhagic lungs, perform Continuous Monitoring Mode at a Pump flow of 1.5 L/min to avoid additional fluid leakage into the alveolar space with a higher Pump flow.
  • Page 46 Chapter 4: Activities Performed at Donor Site Figure 4.25: Connecting Lung Monitoring Gas Cylinder to the Monitoring Port of OCS™ Lung System 2. Increase the Pump flow gradually to 2-3 L/min (unless the lungs are mildly injured). a. Press the Pump adjust button and gradually increase the Pump flow to 2-3 L/min while maintaining a mean PA pressure below 20 mmHg.

  • Page 47: Preservation Mode

    After baseline Continuous Monitoring Mode and prior to leaving the donor site, confirm the alarm limits are set to the recommended ranges below (see Table 4.5). For instructions on how to set alarms, please refer to the TransMedics Technical User Guide: OCS ™...
  • Page 48 ™ Lung System users to manage the lungs as needed during transport. For instructions on how to set or change the lower graphic display on the Monitor’s screen, please refer to the TransMedics Technical User Guide: OCS ™ Lung System.

  • Page 49: Chapter 5: Activities Performed During Preservation And Transport49

    ™ parameters will help OCS Lung System users to manage the lungs as needed during transport (see detailed settings in Figure 5.1). For more information, please refer to the TransMedics Technical User Guide: OCS ™ Lung System. Figure 5.1: Monitor Picture with Bottom Graphic Frame Set in Preservation Mode to Display VR Trend vs.

  • Page 50: Managing The Lung And Ocs™ Lung System During Preservation And Transport

    Chapter 5: Activities Performed During Transport 4. Have all supplies needed for transport to the recipient site (e.g., Lung Preservation Termination Set, gas wrench, Mobile base, Corrective Medications, Cooler and all other routine retrieval items). 5. Press the release buttons on the push handle, lock in the upright position, and push the system to the vehicle loading area.
  • Page 51 Chapter 5: Activities Performed During Transport Gas Flow: 300 ml/min. Refer to Section 7 for when the Lung Preservation Gas flow rate is recommended to be set higher. Ventilator Settings: • PEEP = keep at 7 cmH O throughout preservation except during flights, reduce PEEP to 5 •...

  • Page 52: Chapter 6: Activities Performed At Recipient Site

    Chapter 6: Activities Performed at Recipient Site CHAPTER 6: ACTIVITIES PERFORMED AT RECIPIENT SITE This chapter provides instructions for the tasks that are performed upon returning to the recipient site. 6.1. Final Recruitment in Preservation Mode Timing: • If recruitment of the donor lungs is clinically required, we recommend that you initiate it at least 30 to 60 minutes before performing final assessment on the OCS ™...
  • Page 53 Chapter 6: Activities Performed at Recipient Site • During Continuous Monitoring Mode, FiO = 21% (room air) Performing Continuous Monitoring Mode (Final): 1. Connect the Lung Monitoring Gas cylinder to the Monitoring port on the OCS™ Lung Console and open its valve (turn in a counter-clockwise direction). 2.
  • Page 54 Chapter 6: Activities Performed at Recipient Site • Glucose level to ensure it is ≥ 120 mg/dL. For low glucose (≤ 120 mg/dL), add 1-2 grams of dextrose. 6.2.2. Physical Bronchoscope Monitoring The OCS™ Lung System has the capability of conducting a Bronchoscopic examination while the lungs are inflated on the device.

  • Page 55: Implantation Decision

    Chapter 6: Activities Performed at Recipient Site b. Using the rotary knob, highlight and select Preservation and press the knob again. c. Confirm switching to Preservation Mode by highlighting the “Accept” option and acknowledge the selection using the rotary knob. d.
  • Page 56 Chapter 6: Activities Performed at Recipient Site NOTE— To maintain warmth and humidity, keep the Lung Organ Chamber cover closed throughout the procedure until the lung is ready to be disconnected from the OCS™ Lung System. ™ Double Lung Flush Using Cold Buffered OCS Lung Solution: •...
  • Page 57 Chapter 6: Activities Performed at Recipient Site Figure 6.3: Connecting the Lung Flush Collection Bag to the Oxygenator Recirculation Line 4. Hang at least 3 L of cold buffered OCS™ Lung Solution from an IV pole. Attach one bag of solution at a time to the Termination Flush Line.
  • Page 58 Chapter 6: Activities Performed at Recipient Site Figure 6.5: Making a Wet-to-Wet Connection 9. To deliver flush solution to the lung, open the LPM Termination flush stopcock (Figure 6.6). Figure 6.6: Delivering Flush Solution 10. Immediately after starting delivery of the cold flush solution, clamp the PA line of the LPM below the level of the flush port using a hemostat or other surgical clamping instrument (Figure 6.7).
  • Page 59 Chapter 6: Activities Performed at Recipient Site a. Press the Pump adjust button on the Wireless Monitor b. Turn the rotary knob all the way to the left (counter-clockwise) until the Pump is turned off and the Wireless Monitor displays the icon on the screen indicating the Pump is off (Figure 6.8).

  • Page 60: Performing The Shut-Down Protocol

    After the lung has been removed, detach the Flow, SaO /Hematocrit, and SvO /Hematocrit probes from the tubing, clean the probes as described in Chapter 8 of the TransMedics Technical User Guide: OCS ™ Lung System, and store them inside the Lung System.

  • Page 61: Disconnecting The Ventilator Lines

    Chapter 6: Activities Performed at Recipient Site 2. Carefully remove the flow probe from the tubing on the LPM, but leave it connected to the OCS™ Lung Console. To remove the SvO /Hematocrit and SaO /Hematocrit probes from the tubing: 1.

  • Page 62: Preparing The Ocs™ Lung System For Storage

    Chapter 6: Activities Performed at Recipient Site 6.11. Preparing the OCS™ Lung System for Storage 1. Disconnect the system from AC power. 2. Clean the system by following the instructions in the TransMedics Technical User Guide: ™ Lung System. 3. Reinstall the top cover.

  • Page 63: Chapter 7: Critical Scenarios And Troubleshooting

    Chapter 7: Critical Scenarios and Troubleshooting CHAPTER 7: CRITICAL SCENARIOS AND TROUBLESHOOTING If any of the problems described in this chapter or other problems present themselves, please contact TransMedics at: • US/AUS/Canada: +1 978-222-3733 • EUR: +31(0) 20-7084561 7.1. If PEEP Can Not Be Maintained During Preservation Mode Refer to the screen shot in Figure 7.1.

  • Page 64: If Mean Pap, Vr, And/Or Pawp Is Rising At Same Ventilation And Perfusion Settings, Manage As Follows

    Chapter 7: Critical Scenarios and Troubleshooting Figure 7.2: Lung Injury with Blood Froth 7.2. If Mean PAP, VR, and/or PAWP is Rising at Same Ventilation and Perfusion Settings, Manage as Follows: • Ensure correct drainage of pulmonary veins. • Look for a missed lung injury, fix, and manage accordingly. •...

  • Page 65: Appendix A. Ocs Lung System Inspire Study

    Appendix A: OCS ™ Lung System INSPIRE Study APPENDIX A. OCS ™ LUNG SYSTEM INSPIRE STUDY 1. Background Lung transplantation is the mainstay of therapy for a variety of end-stage lung diseases such as pulmonary fibrosis, cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), and primary pulmonary hypertension (PPH).
  • Page 66 Appendix A: OCS ™ Lung System INSPIRE Study Subjects were randomized to either the standard cold static organ preservation (Control) or to the ™ Lung System (OCS ™ 2.1. Primary Effectiveness Endpoint is a form of acute lung injury that is a known serious complication of lung transplantation. The most severe form (PGD3) has been shown to be correlated with poor short and long-term outcomes, including reduced survival and increased incidence of Bronchiolitis Obliterans Syndrome (BOS) (Huang et al.
  • Page 67 30 days) was also collected. Assessing survival through initial transplant hospital discharge, even if longer than 30 days, captures patients who never recovered following their transplantation surgery and died in hospital. TransMedics performed a post-hoc adjunct composite effectiveness endpoint analysis that evaluated survival throughout 30 days and initial hospital discharge and absence of PGD3 within the first 72 hours post-transplantation.
  • Page 68 OCS™ Lung Solution or a commercially available LPD solution. ™ However, during the course of the INSPIRE Trial, TransMedics experienced a shortage of the OCS Lung Solution as it was transitioning from one contract manufacturer to another. During this time, ™...
  • Page 69 Appendix A: OCS ™ Lung System INSPIRE Study Results for the OCS Solution subgroup (only subjects perfused with the OCS™ Lung Solution that is approved for use with the OCS™ Lung System) are presented in Section 15.4. Results for the INSPIRE Initial Cohort (N=320), i.e.
  • Page 70 Appendix A: OCS ™ Lung System INSPIRE Study Figure 2: INSPIRE Trial Enrollment Detailed Consort Diagram Randomized Subjects Control N=407 N=199 N=208 Screen Failures Screen Failures N=43 N=15 mITT Population Control OCS Arm N= 165 N=349 N=184 LPD Solution OCS Solution N= 61 N= 104 Lung Turn Down...
  • Page 71 Appendix A: OCS ™ Lung System INSPIRE Study 6. Demographic and Baseline Information Recipient characteristics are shown in Table 2 below. The two groups were similar in all categories and where small differences were observed, the recipients tended to have more risk factors in the OCS Arm than Control;...
  • Page 72 Appendix A: OCS ™ Lung System INSPIRE Study Parameter Control OCS Arm OCS Solution (N=184) (N=165) Subgroup (N=104) Type of Status Urgent 84.3% (43/51) 82.7% (43/52) 82.4% (28/34) High-Urgent 15.7% (8/51) 17.3% (9/52) 17.6% (6/34) Lung Allocation Score Mean ± SD 47.57 ±...
  • Page 73 Appendix A: OCS ™ Lung System INSPIRE Study Parameter Control OCS Arm OCS Solution (N=184) (N=165) Subgroup (N=104) Median 42.0 44.0 43.0 Min.-Max. 14.0 - 63.0 13.0 - 64.0 13.0 - 63.0 Gender n=184 N=165 N=104 Female 39.7% (73/184) 47.3% (78/165) 51.0% (53/104) Male 60.3% (111/184)
  • Page 74 Appendix A: OCS ™ Lung System INSPIRE Study Figure 3: OCS™ Lung Perfusion Parameters and PF Ratio for OCS Arm 7.2. Total Cross Clamp and Ischemic Times In the Control cold storage preservation arm, the donor lungs are ischemic from the time they are removed from the donor body until the release of the cross clamp in the recipient.
  • Page 75 Appendix A: OCS ™ Lung System INSPIRE Study ™ The OCS Lung System reduced ischemic time for the donor lungs by an average of 2+ hours compared to Cold Storage, despite longer cross-clamp time. See Figure 5 below. Figure 5: Total Cross Clamp and Ischemic Times on Transplanted Lungs (mITT Population) 8.
  • Page 76 ™ Appendix A: OCS Lung System INSPIRE Study The results for the initial primary effectiveness endpoint of survival at day 30 and freedom from PGD3 at the last timepoint of T72 hours are shown in Figure 7 below. Non-inferiority was not shown in the mITT or PP populations.
  • Page 77 Appendix A: OCS ™ Lung System INSPIRE Study Figure 8: 30-Day Patient Survival, INSPIRE Combined Cohort 8.2. PGD3 Component of The Primary Composite Endpoint – PGD3 within 72 Hours and PGD3 at T72: Figure 9 below provides the results for the other component of the amended composite primary endpoint, i.e., the incidence of PGD3 within the initial 72 hours post-transplantation.
  • Page 78 Appendix A: OCS ™ Lung System INSPIRE Study The results for the other component of the initial primary composite endpoint, PGD3 at T72, are shown in Figure 10 below. The incidence of PGD3 at T72 hours was similar between both groups and was low overall.
  • Page 79 Appendix A: OCS ™ Lung System INSPIRE Study Parameter Control (N=180) OCS Arm (N=154) 95% CI for Proportion² (6.5%, 16.1%) (8.1%, 19.3%) π - π (%) (one-sided 95% CI)³ 2.4% (-∞, 8.2%) Control p-value of non-Inferiority test⁴ 0.0746 Patient survival at day 30 post-transplantation Proportion (π) (%) (n/N)¹...
  • Page 80 Appendix A: OCS ™ Lung System INSPIRE Study 10. Safety Endpoint The results for the safety endpoint (i.e., the average number of LGRSAEs through 30 days post- transplant) for the Combined Cohort Safety Population are shown in Table 6 below. The safety ™...
  • Page 81 These results are shown in Figure 12 below. BOS is a chronic condition that develops between 2 and 5 years following lung transplantation. TransMedics will evaluate this trend for 5 years post-transplant in our post-market study.
  • Page 82 BOS-free survival at 24 months after transplantation compared to the cold storage standard of care. These results are shown in Figure 13 below. BOS is a chronic condition that develops between 2 and 5 years following lung transplantation. TransMedics will evaluate this trend for 5 years post-transplant in our post-market study.
  • Page 83 Appendix A: OCS ™ Lung System INSPIRE Study Figure 14: Improvements in Ventilation Time, ICU Time, and Hospitalization (INSPIRE Combined Cohort PP) Figure 15: Improvements in Ventilation Time, ICU Time, and Hospitalization (INSPIRE Combined Cohort mITT) 15. Adjunct Effectiveness Post-hoc Analyses 15.1.
  • Page 84 Adjunct Effectiveness Analysis: Survival at Day 30 and at Initial Hospital Discharge and Freedom from PGD3 within 72 Hours TransMedics performed a post-hoc adjunct composite effectiveness endpoint analysis that evaluated the same components of the primary effectiveness endpoint (short term survival and freedom of PGD3 in the first 72 hours);...
  • Page 85 Appendix A: OCS ™ Lung System INSPIRE Study Figure 17: Adjunct Effectiveness Composite Analysis of Survival Through Initial Hospital Discharge and Freedom from PGD3 Within 72 Hours Post-transplant (INSPIRE Combined Cohort – PP & mITT) 15.3. Adjunct Effectiveness Analysis: Survival at Day 30 and at Initial Hospital Discharge and Freedom from PGD3 at 72 Hours An additional post-hoc adjunct analysis was performed that evaluated the composite of PGD3 at T72 and survival throughout 30 days and initial hospital discharge.
  • Page 86 Appendix A: OCS ™ Lung System INSPIRE Study The results for the amended Primary Endpoint are shown in Figure 19 below, and the results for the initial composite primary endpoint are shown in Figure 20 below. The results for one component of the amended primary endpoint (i.e., PGD within 72 hours) are shown in Figure 21, and the results for one component of the initial primary endpoint, PGD3 at T72 are provided in Figure 22.
  • Page 87 Appendix A: OCS ™ Lung System INSPIRE Study Figure 20: Results for Initial Primary Effectiveness Endpoint: Survival at Day 30 Post- Transplantation and Absence of PGD3 at 72 Hours, OCS Solution Subgroup, OCS Arm and Control, INSPIRE Combined Cohort Figure 21: Results for Incidence of PGD3 within 72 Hours: OCS Solution Subgroup, OCS Arm, and Control, INSPIRE Combined Cohort Proportion...
  • Page 88 Appendix A: OCS ™ Lung System INSPIRE Study Figure 22: Results for Incidence of PGD3 at 72 Hours: OCS Solution Subgroup, OCS Arm, and Control, INSPIRE Combined Cohort 10.0 Proportion n=184 n=165 n=104 n=180 n=154 N=99 mITT Control OCS Solution Subgroup Table 7: Secondary Endpoints: OCS Solution Subgroup compared to OCS Arm and Control group, PP Population, INSPIRE Combined Cohort...
  • Page 89 Appendix A: OCS ™ Lung System INSPIRE Study Parameter Control (N=180) OCS Arm (N=154) OCS Solution (N=99) The 95% upper confidence limit is for the difference between the two population proportions (π -π Control secondary endpoints 1 and 2. π -π...
  • Page 90 Appendix A: OCS ™ Lung System INSPIRE Study The results for the amended Primary Endpoint for the INSPIRE Initial Cohort are shown in Figure 23 below, and the results for the initial primary endpoint are shown in Figure 24 below. The results for both analyses are similar.
  • Page 91 Appendix A: OCS ™ Lung System INSPIRE Study Figure 24: Results for Initial Composite Primary Endpoint (30-Day Survival and Freedom from PGD3 at 72 Hours) for the INSPIRE Initial Cohort (N=320) Figure 25: Incidence of PGD3 within 72 hours, PP and mITT Populations, INSPIRE Initial Cohort (N=320) Proportion n=169...
  • Page 92 Appendix A: OCS ™ Lung System INSPIRE Study Figure 26: Incidence of PGD3 at T72 hours, PP and mITT Populations, INSPIRE Initial Cohort (N=320) 10.0 Proportion n=169 n=151 n=90 n=165 n=141 N=86 mITT Control OCS Solution Subgroup Table 9: Secondary Endpoints: INSPIRE Initial Cohort, PP Population Parameter Control (N=165) OCS Arm (N=141)
  • Page 93 Appendix A: OCS ™ Lung System INSPIRE Study Parameter Control (N=165) OCS Arm (N=141) OCS Solution (N=86) π = n/N *100% = simple proportion. The 95% confidence interval was calculated based on the Clopper-Pearson method. The 95% upper confidence limit is for the difference between the two population proportions (π -π...
  • Page 94 ™ Lung System TOTAL TransMedics has addressed the observed malfunctions with design and manufacturing improvements that were implemented and used during the INSPIRE Trial to minimize the potential for recurrence as described below: • The filter assembly components of the LPM were modified to improve the efficiency and capacity of these sub-components, thereby improving perfusate flow from the organ chamber to the reservoir.
  • Page 95 Appendix A: OCS ™ Lung System INSPIRE Study 18. Summary of Adverse Events An overall summary of adverse events is presented in Table 12 below, and the serious adverse events (SAEs) are shown in Table 13 below, presented by MEDRA preferred term. Both analyses are for the safety population (N=348).
  • Page 96 Appendix A: OCS ™ Lung System INSPIRE Study Table 13: Adjudicated Serious Adverse Events by Preferred Term that occurred in ≥ 1% of Subjects; Safety Population (N=348) System Organ Class and Preferred Term Control n (%) OCS Arm n (%) OCS Solution n (%) Patients Events...
  • Page 97 Appendix A: OCS ™ Lung System INSPIRE Study System Organ Class and Preferred Term Control n (%) OCS Arm n (%) OCS Solution n (%) Patients Events Patients (N=164) Events (N=192) Patients Events (N=184) (N=247) (N=103) (N=118) Lung infection pseudomonal 1 (0.5) 1 (0.4) 3 (1.8)
  • Page 98 Appendix A: OCS ™ Lung System INSPIRE Study System Organ Class and Preferred Term Control n (%) OCS Arm n (%) OCS Solution n (%) Patients Events Patients (N=164) Events (N=192) Patients Events (N=184) (N=247) (N=103) (N=118) Deep vein thrombosis 1 (0.5) 1 (0.4) 4 (2.4)
  • Page 99 Appendix A: OCS ™ Lung System INSPIRE Study System Organ Class and Preferred Term Control n (%) OCS Arm n (%) OCS Solution n (%) Patients Events Patients (N=164) Events (N=192) Patients Events (N=184) (N=247) (N=103) (N=118) Delirium 2 (1.1) 2 (0.8) 0 (0.0) 0 (0.0)
  • Page 100 • The OCS Arm in the INSPIRE Trial has shown numerically lower incidence of BOS through 24 months after transplant compared to cold storage. BOS is a chronic condition that develops between 2 and 5 years following lung transplantation. TransMedics will evaluate this trend in our post-market registry study.

  • Page 101: Appendix B. Body Weight Formula

    Appendix B: Body Weight Formula APPENDIX B. BODY WEIGHT FORMULA *Devine’s formula for a suggested ideal body weight calculation for person’s height over 5 feet (150 cm) is provided below: * Paul L. Marino. (1998). The ICU Book. (Second edition). Maryland: Lippincott Williams & Wilkins. p 872 *Devine, Ben J (1974).

  • Page 102: Appendix C. Primary Graft Dysfunction Classification Used In Inspire Trial

    Appendix C: Primary Graft Dysfunction Classification used in INSPIRE Trial APPENDIX C. PRIMARY GRAFT DYSFUNCTION CLASSIFICATION USED IN INSPIRE TRIAL The INSPIRE Trial used the Consensus Statement for assessment of PGD that was published by the ISHLT in 2005 as listed above. The clinical implementation of the caveats was defined by the INSPIRE Senior Investigator Steering Committee as follows: •...
  • Page 103 Tel: +1 978 552 0900 Service: +1 978 552 0999 Fax: +1 978 552 0978 Website: www.transmedics.com Software Version 3.1.2 PN 100004071, Rev 5 REF 2102 © 2018 by TransMedics, Inc. All rights reserved. Printed in U.S.A. PN 100004071, Rev 5 Page 103...

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