CARDIOVASCULAR
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Optisure™

Defibrillation Lead

OptisureDefibrillation Lead

DESCRIPTION

The Optisure™ lead expands on the St. Jude Medical high-voltage product portfolio, providing an additional system enhancement for addressing lead complications and improving system reliability.


PRODUCT HIGHLIGHTS

  • Building on the proven 7 F Durata™ lead design, the Optisure lead features additional Optim™ insulation at the proximal end of the lead, and under the SVC coil resulting in an 8 F lead body.
    • Optim™ insulation is a chemical co-polymer that offers superior handling and durability.1
  • Two innovative designs are intended to help prevent tissue ingrowth – flat-wire technology provides a low profile for the defibrillation coils, and silicone backfilling completely fills the shock coil space.
  • Redundant conductors serve as a backup system in the unlikely event of a conductor failure.
  • Symmetrically aligned cables within the lead body and centrally located coil provide for additional protection to the inner coil.2
  • The DF4 connector is designed to simplify implants by streamlining defibrillation connections into a single terminal pin and reducing the number of set screws.

ORDERING INFORMATION

Contents: Defibrillation lead


Reorder Number Insulation Fixation Minimum Introducer (F) Shock Configuration Sensing Tip-to-Proximal Coil (cm) Connector Lengths (cm)
LDA220-65 Optim Ext/Ret Helix 8 Dual-coil True bipolar 17 DF1; IS-1 65
LDA220Q-52 Optim Ext/Ret Helix 8 Dual-coil True bipolar 17 DF4 52
LDA220Q-58 Optim Ext/Ret Helix 8 Dual-coil True bipolar 17 DF4 58
LDA220Q/65 Optim Ext/Ret Helix 8 Dual-coil True bipolar 17 DF4 65*
LDA230Q-65 Optim Ext/Ret Helix 8 Dual-coil True bipolar 21 DF4 65
LDA210-65 Optim Ext/Ret Helix 8 Single-coil True bipolar N/A DF1; IS-1 65
LDA210Q-52 Optim Ext/Ret Helix 8 Single-coil True bipolar N/A DF4 52
LDA210Q/58 Optim Ext/Ret Helix 8 Single-coil True bipolar N/A DF4 58*
LDA210Q-65 Optim Ext/Ret Helix 8 Single-coil True bipolar N/A DF4 65
LDP220Q/65 Optim Tines 8 Dual-coil True bipolar 17 DF4 65

1. Jenney C, Tan J, Karicherla A, Burke J, Helland J. A New Insulation Material for Cardiac Leads with Potential for Improved Performance, Heart Rhythm, 2, S318-S319 (2005).

2. St. Jude Medical Engineering Report: Tension and Cable Shortening Comparison. Report 60032635.


Rx Only

Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications for Use: The Optisure™ transvenous leads are indicated for use with compatible pulse generators (refer to the applicable defibrillator manual for system indications). They provide pacing and sensing and deliver cardioversion/defibrillation therapy to the heart.

Contraindications: Optisure™ leads are contraindicated in the following: Patients with tricuspid valvular disease or a mechanical tricuspid valve. Patients with ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction. Patients for whom a single dose of 1.0 mg of dexamethasone sodium phosphate is contraindicated. For use with extra firm (red color knob) stylets (models LDA220, LDA230, LDA210, LDA220Q, LDA230Q, and LDA210Q).

Potential Adverse Events: Possible adverse events associated with the use of transvenous lead systems include, but are not limited to: Dislodgement, breaching of the lead insulation, connector fracture, poor connection to the pulse generator, electrode fracture, or conductor discontinuity, cardiac perforation, venous perforation, myocardial irritability, transvenous implantation procedure, chronic (> 3 months) implantation, contamination, post-shock rhythm disturbances, threshold elevation or exit block, shunting or insulating of current during defibrillation with internal or external paddles.

Warning: Implanted cardiac leads are subjected to a hostile environment within the body due to constant, complex flexural and torsional forces, interactions with leads and/or the pulse generator, or other forces associated with cardiac contractions and patient physical activity, posture, and anatomical influences. Cardiac leads’ functional lifetimes can be affected by these and other factors. Use only battery-powered equipment when implanting and testing the lead to avoid fibrillation caused by alternating current. Ground all line-powered equipment used near the patient to avoid fibrillation caused by alternating current. Insulate lead connector pins from potential leakage currents from line-powered equipment to avoid fibrillation caused by the leakage current.

Refer to the defibrillator manual for additional complications and precautions specific to the pulse generator.

US-2000157 B EN (03/14)

Last Updated: January 02, 2019

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