Boston Scientific ENDOTAK RELIANCE Series Physician's Manual
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Boston Scientific ENDOTAK RELIANCE Series Physician's Manual

Steroid-eluting extendable/retractable helix endocardial defibrillation leads
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358988-001 EN Europe.book Page 1 Monday, November 24, 2014 11:17 AM
PHYSICIAN'S LEAD MANUAL
ENDOTAK RELIANCE
Steroid-Eluting Extendable/Retractable Helix
Endocardial Defibrillation Leads
ENDOTAK RELIANCE
ENDOTAK RELIANCE S
ENDOTAK RELIANCE G
ENDOTAK RELIANCE SG
0157, 0158
0138
0184, 0185, 0186, 0187
0180, 0181, 0182, 0183
™

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Summary of Contents for Boston Scientific ENDOTAK RELIANCE Series

  • Page 1 358988-001 EN Europe.book Page 1 Monday, November 24, 2014 11:17 AM PHYSICIAN’S LEAD MANUAL ENDOTAK RELIANCE ™ Steroid-Eluting Extendable/Retractable Helix Endocardial Defibrillation Leads ENDOTAK RELIANCE 0157, 0158 ENDOTAK RELIANCE S 0138 ENDOTAK RELIANCE G 0184, 0185, 0186, 0187 ENDOTAK RELIANCE SG 0180, 0181, 0182, 0183...
  • Page 2 358988-001 EN Europe.book Page 2 Monday, November 24, 2014 11:17 AM...
  • Page 3 358988-001 EN Europe.book Page 3 Monday, November 24, 2014 11:17 AM ENDOTAK RELIANCE is a trademark of Boston Scientific or its affiliates.
  • Page 4 358988-001 EN Europe.book Page 4 Monday, November 24, 2014 11:17 AM...

  • Page 5: Table Of Contents

    358988-001 EN Europe.book Page 1 Monday, November 24, 2014 11:17 AM Table of Contents INFORMATION FOR USE ................. 1 Device Description................1 Indications ..................1 Contraindications ................1 Warnings ................... 1 ICD/Lead Compatibility..............2 MRI Exposure................2 Diathermy Exposure..............2 Implantation...................
  • Page 6 358988-001 EN Europe.book Page 2 Monday, November 24, 2014 11:17 AM Checking for Lead Stability .............. 21 Repositioning the Lead ..............21 Evaluating Lead Position ..............21 Minimizing Pacemaker Interaction ..........21 Taking Baseline Measurements ..........22 Electrical Performance..............23 Evaluating with the Pulse Generator ...........

  • Page 7: Information For Use

    ICD automatic implantable cardioverter defibrillator systems. Contraindications Use of this Boston Scientific active fixation lead is contraindicated for the following patients: • Patients who have a unipolar pacemaker. • Patients with a hypersensitivity to a maximum single dose of 1.1 mg dexamethasone acetate.

  • Page 8: Icd/Lead Compatibility

    • In order to deliver defibrillation therapy, the single-coil ENDOTAK RELIANCE S or ENDOTAK RELIANCE SG lead must be implanted with a separate defibrillation electrode. Boston Scientific recommends using the ENDOTAK RELIANCE S or ENDOTAK RELIANCE SG lead with a pectorally implanted device that uses the metallic housing as a defibrillation electrode.

  • Page 9: Conversion Testing

    358988-001 EN Europe.book Page 3 Monday, November 24, 2014 11:17 AM INFORMATION FOR USE Conversion Testing • Use of any component of the ENDOTAK lead system to assist in delivery of external-source rescue shocks could cause extensive tissue damage. (Page 24) •...

  • Page 10: Potential Adverse Events

    358988-001 EN Europe.book Page 4 Monday, November 24, 2014 11:17 AM INFORMATION FOR USE Potential Adverse Events Based on the literature and lead implant experience, the possible physical effects from implantation of an ENDOTAK RELIANCE, ENDOTAK RELIANCE S, ENDOTAK RELIANCE G, or ENDOTAK RELIANCE SG lead are listed below in alphabetical order: •...

  • Page 11: Warranty

    Warranty A limited warranty certificate for the lead is available. For a copy, contact Boston Scientific 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...

  • Page 12: Symbols On Packaging

    358988-001 EN Europe.book Page 6 Monday, November 24, 2014 11:17 AM INFORMATION FOR USE Symbols on Packaging The following symbols may be used on leads packaging and labeling Symbol Definition Opening instructions Do not reuse Do not resterilize Consult instructions for use Sterilized using ethylene oxide Reference number Use by...

  • Page 13: Device Features

    358988-001 EN Europe.book Page 7 Monday, November 24, 2014 11:17 AM DEVICE FEATURES DEVICE FEATURES Detailed Device Description Features of the ENDOTAK RELIANCE active fixation lead family include the following components: • Steroid Distal Tip: The tip electrode contains a nominal dose of 0.89 mg dexamethasone acetate within a silicone collar.
  • Page 14 358988-001 EN Europe.book Page 8 Monday, November 24, 2014 11:17 AM DEVICE FEATURES • Lead Body: The isodiametric lead body contains one conductor for pacing/sensing. The ENDOTAK RELIANCE and ENDOTAK RELIANCE G leads have two conductors for defibrillation and the ENDOTAK RELIANCE S and ENDOTAK RELIANCE SG leads have one conductor for defibrillation.
  • Page 15 358988-001 EN Europe.book Page 9 Monday, November 24, 2014 11:17 AM DEVICE FEATURES Nominal overall lengths of the active fixation leads are as follows: ENDOTAK RELIANCE G 0184 0185 0186 0187 59 cm 64 cm 70 cm 90 cm ENDOTAK RELIANCE SG 0180 0181 0182...

  • Page 16: Lead Evaluation

    358988-001 EN Europe.book Page 10 Monday, November 24, 2014 11:17 AM LEAD EVALUATION LEAD EVALUATION Implant Information Proper surgical procedures and techniques are the responsibility of the medical professional. The described implant procedures are furnished only for informational purposes. Each physician must apply the information in these instructions according to professional medical training and experience.

  • Page 17: Opening Instructions

    (EO) 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 Boston Scientific at the address on the back cover of this manual. Never attempt to resterilize the lead.

  • Page 18: Fixation Tool

    358988-001 EN Europe.book Page 12 Monday, November 24, 2014 11:17 AM LEAD EVALUATION Fixation Tool The fixation tool can be attached to the terminal pin and rotated clockwise or counterclockwise for extending or retracting the helix (Figure 3). Figure 3. The fixation tool. Stylets Firm and soft positioning stylets are packaged with each lead.

  • Page 19: Vein Pick

    358988-001 EN Europe.book Page 13 Monday, November 24, 2014 11:17 AM LEAD EVALUATION Use the following instructions during the implant procedure: 1. Following insertion of the hemostatic introducer into the vein and removal of the dilator, hold your thumb over the proximal exposed open- ing of the TVI tool and insert the distal end of the TVI tool into the proxi- mal end of the hemostatic introducer by gently pushing the TVI tool through the hemostatic valve.

  • Page 20: Lead Caps

    • Do not apply oil-based lubricants to the ePTFE-covered shocking coils. (ENDOTAK RELIANCE G and ENDOTAK RELIANCE SG models only) Note: Boston Scientific suggests using sterile water if a lubricant is needed when coupling the lead with the ICD pulse generator.

  • Page 21: Implantation

    358988-001 EN Europe.book Page 15 Monday, November 24, 2014 11:17 AM IMPLANTATION IMPLANTATION Inserting the Stylet Choose a stylet according to the function and to the firmness desired. Remove the preinserted stylet before inserting a different one. Make sure the stylet is fully inserted in the lead prior to inserting the lead into the vein. Gently curve the preferred straight stylet with any sterile, smooth-surfaced instrument (eg, 10- or 12-cc syringe barrel) (Figure 8) and...

  • Page 22: Inserting The Lead

    • Percutaneously or via cutdown through the subclavian vein or internal jugular vein-typically the left subclavian or right internal jugular vein. • A 9F subclavian introducer set is available from Boston Scientific for use during percutaneous lead insertion. • When using a hemostatic tear-away introducer, use the TVI tool packaged with this lead.
  • Page 23 358988-001 EN Europe.book Page 17 Monday, November 24, 2014 11:17 AM IMPLANTATION Leads placed by percutaneous subclavian venipuncture should enter the subclavian vein where it passes over the first rib (rather than more medially) to avoid entrapment by the subclavius muscle or ligamentous structures associated with the narrow costoclavicular region.

  • Page 24: Positioning The Lead

    358988-001 EN Europe.book Page 18 Monday, November 24, 2014 11:17 AM IMPLANTATION 4. Press a thumb against the index finger and project one or two centimeters below the clavicle to shield the subclavius muscle from the needle (when hypertrophy of the pectoralis muscle is apparent, the thumb should project about two centimeters below the clavicle because the subclavius muscle should be hypertrophied as well) (Figure 10).

  • Page 25: Lead Fixation

    • In order to deliver defibrillation therapy, the single-coil ENDOTAK RELIANCE S and ENDOTAK RELIANCE SG leads must be implanted with a separate defibrillation electrode. Boston Scientific recommends using the ENDOTAK RELIANCE S and ENDOTAK RELIANCE SG leads with a pectorally implanted device that uses the metallic housing as a defibrillation electrode.
  • Page 26 358988-001 EN Europe.book Page 20 Monday, November 24, 2014 11:17 AM IMPLANTATION 1. When the correct position has been achieved, attach the fixation tool to the terminal pin. Press the handles together and place the pin in the preformed groove. Release the tension on the handles to secure the terminal pin in the fixation tool (Figure 13).

  • Page 27: Checking For Lead Stability

    358988-001 EN Europe.book Page 21 Monday, November 24, 2014 11:17 AM IMPLANTATION 4. Remove the fixation tool from the terminal pin by pressing the handles of the tool together. If the helix mechanism fails to function properly during repositioning, the following caution must be carefully observed to avoid possible tissue snagging when removing the lead: CAUTION: Do not use the lead if the helix cannot be retracted during...

  • Page 28: Taking Baseline Measurements

    358988-001 EN Europe.book Page 22 Monday, November 24, 2014 11:17 AM IMPLANTATION • After implanting the pacing leads, examine the signals from the pace/ sense electrodes to ensure that minimal pacemaker artifacts are present. (Use a recording system that has a bandwidth of at least 2000 Hz to ensure that minimal pacemaker artifacts are present.) •...

  • Page 29: Electrical Performance

    Electrical Performance Make the lead connections and evaluate the lead signals using either the pulse generator or a Boston Scientific PRM. WARNING: When connecting the lead to the ICD pulse generator, it is very important that proper connections are made. Damage to the heart could result if a high-voltage defibrillating pulse were to be delivered through the pace/sense tip electrode.

  • Page 30: Evaluating With The Prm

    Reliable conversion of VF should be demonstrated at an energy level less than the maximum energy setting of the pulse generator. Boston Scientific recommends that multiple induction conversion tests of VF be performed to determine conversion reliability and the patient’s defibrillation threshold...

  • Page 31: Securing The Lead

    358988-001 EN Europe.book Page 25 Monday, November 24, 2014 11:17 AM IMPLANTATION If a patient’s arrhythmia(s) cannot be reliably converted with an ENDOTAK RELIANCE, ENDOTAK RELIANCE S, ENDOTAK RELIANCE G, or ENDOTAK RELIANCE SG lead, supplementary implantation of an alternate lead system will require additional conversion testing. WARNING: Use of any component of the ENDOTAK lead system to assist in delivery of external-source rescue shocks could cause extensive tissue damage.

  • Page 32: Venous Cut-Down Technique

    358988-001 EN Europe.book Page 26 Monday, November 24, 2014 11:17 AM IMPLANTATION 4. Check the suture sleeve after tie-down to demonstrate stability and lack of slippage by grasping the suture sleeve with fingers and trying to move the lead in either direction. Venous Cut-Down Technique 1.

  • Page 33: Abdominal Implants

    Capping the terminal pin protects it and prevents body fluids from entering the lumen of the lead. Note: When using a Boston Scientific lead tunneler, do not cap the leads. CAUTIONS: • Tunnel the lead from the chest area to the pulse generator implant site.

  • Page 34: Connection To A Pulse Generator

    358988-001 EN Europe.book Page 28 Monday, November 24, 2014 11:17 AM IMPLANTATION Connection to a Pulse Generator Consult the ICD 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

    Use a Boston Scientific Returned Product Kit to properly package the lead and complete an Observation/Complication/Out-of-Service Report form. Send the form and kit to Boston Scientific at the address on the back of this manual.

  • Page 36: Specifications

    358988-001 EN Europe.book Page 30 Monday, November 24, 2014 11:17 AM SPECIFICATIONS SPECIFICATIONS Table 3. Model Number and Lead Length Model Length Single Coil Leads ENDOTAK RELIANCE S 0138 64 cm ENDOTAK RELIANCE SG 0180 59 cm 0181 64 cm 0182 70 cm 0183...
  • Page 37 Tip electrode (helix) Platinum iridium ePTFE Coil electrode covering (GORE models only: 0180, 0181, 0182, 0183, 0184, 0185, 0186, 0187) Steroid Dexamethasone acetate (DXA) Compatibility Boston Scientific ICD pulse generators a. Use fluoroscopy markers for verification of full extension/retraction of helix.
  • Page 38 358988-001 EN Europe.book Page 32 Monday, November 24, 2014 11:17 AM SPECIFICATIONS Table 5. Lead Introducer Recommended lead Without guide wire With guide wire introducer size 10.5F (3.5 mm) 9F (3.0 mm) Non-hemostatic (All single and dual coil (All single and dual coil introducer models) models)
  • Page 39 358988-001 EN Europe.book Page 1 Monday, November 24, 2014 11:17 AM...
  • Page 40 PO Box 332 BOTANY NSW 1455 Australia Free Phone 1 800 676 133 Free Fax 1 800 836 666 www.bostonscientific.com 1.800.CARDIAC (227.3422) +1.651.582.4000 © 2014 Boston Scientific Corporation or its affiliates. All Rights Reserved. 358988-001 EN Europe 2020-01 Authorized 2002 *358988-001*...

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