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Summary of Contents for Boston Scientific ENDOTAK RELIANCE
- Page 1 PHYSICIAN’S LEAD MANUAL ENDOTAK RELIANCE ® ENDOTAK RELIANCE ® Steroid-Eluting Tined Endocardial Defibrillation Leads 0147/0148 0128 RESTRICTED DEVICE: Federal law (USA) restricts the sale, distri- bution, or use of this device to, by or on the lawful order of a physician.
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Page 4: Table Of Contents
Table of Contents INFORMATION FOR USE ..........1 Device Description............1 Indications ..............1 Contraindications ............1 Warnings ..............1 AICD/Lead Compatibility .......... 2 MRI Exposure............2 Diathermy Exposure..........2 Implanting..............2 Electrical Performance ..........3 Conversion Testing ..........3 Securing and Tunneling ........... - Page 5 Checking for Lead Stability......... 22 Evaluating Lead Position..........22 Taking Baseline Measurements......22 Electrical Performance ..........23 Evaluating with the Pulse Generator...... 24 Evaluating with the PRM ........24 Conversion Testing ............ 24 Securing the Lead ............26 Percutaneous Implant Technique ......26 Venous Cut-Down Technique ........
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Page 6: Information For Use
S lead, Model 0128, are steroid-eluting, tined, endocardial cardioversion/defibrillation and pace/sense leads. The ENDOTAK RELIANCE lead (dual coil) and the ENDOTAK RELIANCE S lead (single coil) are for use as an integral part of an AICD automatic implantable cardioverter defibrillator system with DF-1 and IS-1 ports. -
Page 7: Aicd/Lead Compatibility
• In order to deliver defibrillation therapy, the single-coil ENDOTAK RELIANCE S lead must be implanted with a separate defibrillation electrode. Boston Scientific recom- mends using the ENDOTAK RELIANCE S lead with a pec- torally implanted device that uses the metallic housing as a defibrillation electrode. (Page 21) -
Page 8: Electrical Performance
• Refer to the Implant Information, Implantation, and Post-Implant Evaluation sections of this manual for cau- tions specific to handling, implanting, and testing the ENDOTAK RELIANCE lead family. Failure to observe 1. Physicians' Desk Reference is a trademark of Thomson Healthcare, Inc. -
Page 9: Adverse Events
Given the similar design features, including the porous tip electrode, steroid performance, and high pacing impedance, the ENDOTAK ENDURANCE Rx clinical investigation was used to support the ENDOTAK RELIANCE or ENDOTAK RELIANCE S lead. The following are the adverse events reported in that investigational study. -
Page 10: Potential Adverse Events
INFORMATION FOR USE Table 1. ENDOTAK ENDURANCE Rx lead Study Complications and Observations # of # of % of # of leads (n = 98) (95% Cl) (n = 98) 2.0% Complications (all types) (0.0–4.8%) 1.0% Hematoma (0.0–3.0%) 1.0% Noncapture (connector) (0.0–3.0%) 6.0% Observations... -
Page 11: Clinical Trial
INFORMATION FOR USE RELIANCE or ENDOTAK RELIANCE S lead are listed below in alphabetical order: • Air embolism • Lead displacement/ • Allergic reaction dislodgment • Lead fracture, insulation • Arterial damage with break subsequent stenosis • Lead tip deformation and/or •... -
Page 12: Clinical Investigation
INFORMATION FOR USE used to support the ENDOTAK RELIANCE or ENDOTAK RELIANCE S lead. The following is a summary of findings from the ENDOTAK ENDURANCE Rx Lead Clinical Investigation. In clinical application, dexamethasone sodium phosphate is functionally equivalent to dexamethasone acetate. The dexamethasone sodium phosphate steroid plug was used in the clinical study. - Page 13 INFORMATION FOR USE Table 2. Description of the Study Population (n = 98) Primary Arrhythmia Other Primary Cardiac Disease Coronary artery disease Cardiomyopathy Other Lead measurements were recorded at implant, predischarge, 1 month, and 3 month follow-up visits. The results in Table 3 and Table 4 show a statistically significant difference in impedance and threshold values when comparing the ENDOTAK ENDURANCE Rx lead and the control lead.
- Page 14 INFORMATION FOR USE the control lead, and the nominal industry standard in terms of lead impedance. ENDOTAK ENDURANCE Control (ENDOTAK DSP) Industry Standard 3 Months Implant 1 Month Time Figure 1. ENDOTAK ENDURANCE Rx lead impedance by follow-up period. (n=98) Pacing thresholds measured at implant, predischarge, 1 month and 3 month follow-up visits were compared to the historical control to demonstrate lower pacing threshold performance.
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Page 15: Warranty
Warranty A limited warranty certificate for the lead is available For a copy, please contact Boston Scientific Corporation using the information on the back cover. Refer to the Contraindications, Warnings, Precautions, and Adverse Events sections of this manual for information concerning the performance of this device. -
Page 16: Device Features
The proximal coil Electrode on the ENDOTAK RELIANCE lead is intended to serve as an anode or cathode for cardioversion/defibrillation shocks. The ENDOTAK RELI- ANCE S lead uses the implanted device’s metallic housing... - Page 17 • Terminals: The ENDOTAK RELIANCE lead has three ter- minals: two DF-1 (shock), and one IS-1 bipolar (pace/ sense). The ENDOTAK RELIANCE S lead has one DF-1 (shock) terminal and one IS-1 terminal (pace/sense).The...
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Page 18: Lead Evaluation
LEAD EVALUATION 18 cm Figure 2. Electrode spacing for the ENDOTAK RELIANCE lead is measured from the distal tip to the distal end of the proximal coil Electrode. LEAD EVALUATION Implant Information Proper surgical procedures and techniques are the responsibility of the medical professional. The described implant procedures are furnished for informational purposes only. -
Page 19: Opening Instructions
(EtO) before final packaging. When they are received, they are sterile and ready for use. If the container is wet, damaged, punctured, or if the seal is broken, return the lead to the nearest Boston Scientific representative. Never attempt to resterilize the lead. Surgical Preparation... -
Page 20: Suture Sleeves
LEAD EVALUATION Suture Sleeves Suture sleeves are an adjustable, tubular Figure 3. The long tapered reinforcement positioned over end of the suture sleeve the outer lead insulation (Figure faces toward the vein. 3). They are designed to secure and protect the lead at the venous entry site after distal electrode fixation. -
Page 21: Lead Caps
LEAD EVALUATION To use the vein pick during a cutdown procedure, isolate and open the selected vein using an appropriate scalpel or scissors. Introduce the point of the vein pick via this incision into the lumen of the vein Figure 5. Using the vein pick. (Figure 5). -
Page 22: Implantation
Scientific porous-tipped lead electrode. Mineral oil on the porous tip may inhibit tissue ingrowth and conduction. Note: Boston Scientific suggests using sterile water if a lubri- cant is needed when coupling the lead with the AICD pulse generator . - Page 23 (rather than more medially) to avoid entrapment by the subclavius muscle or ligamentous structures associated with the narrow costoclavicular region. Boston Scientific recommends introducing the lead into the subclavian vein near the lateral border of the first rib. The syringe should be positioned directly above and parallel...
- Page 24 IMPLANTATION Visually draw a line between St and Cp, and divide the segment into thirds. The needle should pierce the skin at the junction of the middle and lateral thirds, directly above the axillary vein (point Ax). Place an index finger on the clavicle at the junction of the medial and middle thirds (point V), beneath which point the subclavian vein should be located.
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Page 25: Positioning The Lead
ENDOTAK RELIANCE leads. the tricuspid valve, and that the proximal coil Electrode (ENDOTAK RELIANCE leads only) is situated in the superior vena cava and high right atrium. Correct functioning of the lead depends on appropriate placement of the electrodes. -
Page 26: Minimizing Pacemaker Interaction
• In order to deliver defibrillation therapy, the single-coil ENDOTAK RELIANCE S lead must be implanted with a separate defibrillation electrode. Boston Scientific recom- mends using the ENDOTAK RELIANCE S lead with a pec- torally implanted AICD pulse generator that uses the metallic housing as a defibrillation electrode. -
Page 27: Checking For Lead Stability
After positioning, partially withdraw the stylet past the most proximal electrode on the ENDOTAK RELIANCE lead or approximately 20 to 25 cm on the ENDOTAK RELIANCE S lead. Check the stability of the lead using fluoroscopy. If possible, have the patient cough or take several deep breaths. -
Page 28: Electrical Performance
IMPLANTATION Table 6. Recommended Lead Signal Parameters Pacing Signal Type Amplitude Duration Impedance Threshold a, b, c a, b, c Pacing/ Ω >5 mV <100 ms <1.5 V 450–1800 Sensing Ω Defibrillation >1 mV <150 ms 20–125 a. Measured approximately 10 minutes after placement. b. -
Page 29: Evaluating With The Pulse Generator
IMPLANTATION age defibrillating pulse were to be delivered through the rate-sensing porous tip electrode. Evaluating with the Pulse Generator Connect the terminal pins to the pulse generator and place the AICD pulse generator into the AICD implant pocket as indicated in the AICD physician’s manual. Also, refer to “Connection to a Pulse Generator”... - Page 30 AICD energy settings and the patient’s ability to tolerate multiple arrhythmia inductions. If a patient’s arrhythmia(s) cannot be reliably converted with an ENDOTAK RELIANCE or ENDOTAK RELIANCE S lead, supplementary implantation of an alternate lead system will require additional conversion testing.
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Page 31: Securing The Lead
IMPLANTATION Note: If, after prolonged and repeated inductions of VF, a tho- racotomy is to be performed, consider performing it at a later date. Securing the Lead After the electrodes are satisfactorily positioned and conversion testing has been performed, secure the lead to the vein to achieve permanent hemostasis and lead stabilization. - Page 32 Note: If venous entry is made using a Boston Scientific lead introducer, ligate the lead to the adjacent fascia using the suture sleeve to prevent lead movement.
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Page 33: Tunneling The Lead To The Abdominal Pocket
Capping the terminal pin protects it and prevents body fluids from entering the lumen of the lead, which may cause lead malfunction. Note: When using a Boston Scientific lead tunneler, do not cap the leads. CAUTIONS: •... -
Page 34: Connection To A Pulse Generator
IMPLANTATION the permanent ligatures and reposition the lead using procedures previously discussed. Connection to a Pulse Generator Consult the AICD physician’s manual for directions concerning connecting the lead terminals to the pulse generator. Verify the stylet is removed prior to connecting the lead to the pulse generator. -
Page 35: Post-Implant Evaluation
Refer to the applicable AICD system manual for specific instructions. Explantation Return all explanted leads to Boston Scientific. Examination of explanted leads may provide information for continued improvement in system reliability. Use a Boston Scientific... -
Page 36: References
REFERENCES REFERENCES DF-1 refers to the international standard ISO 11318:2002. IS-1 refers to the international standard ISO 5841.3:2000. Magney JE, et al. Anatomical mechanisms explaining damage to pacemaker leads, defibrillator leads, and fail- ure of central venous catheters adjacent to the sternocla- vicular joint. -
Page 37: Specifications (Nominal)
0128–64 cm, green 0148–64 cm, green (1) IS-1 bipolar, (1) IS-1 bipolar, Terminal sizes (1) DF-1 (2) DF-1 Compatibility Boston Scientific AICD pulse generators Recommended lead 9 Fr 9 Fr introducer size Tip to proximal coil Elec- 18 cm trode length... -
Page 38: Symbols On Packaging
SYMBOLS ON PACKAGING SYMBOLS ON PACKAGING Symbol Definition Opening instructions Do not reuse Do not resterilize Consult instructions for use Sterilized using ethylene oxide Reference number Use by Date of manufacture Lot number Serial number Manufacturer Do not use if package is damaged... - Page 39 SYMBOLS ON PACKAGING...
- Page 42 Boston Scientific 4100 Hamline Avenue North St. Paul, MN 55112-5798 USA 1.800.CARDIAC (227.3422) +1.651.582.4000 www.bostonscientific.com © 2013 Boston Scientific Corporation or its affiliates. All Rights Reserved. 355456-007 EN US 2013-05 *355456-007*...
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