Durata™ Defibrillation Lead
CARDIOVASCULAR
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Durata™

Defibrillation Lead

Durata<sup>TM</sup>

PRODUCT HIGHLIGHTS

  • Allows patients to safely undergo an MRI scan when used in combination with an St. Jude Medical MRI Ready device.1,2
  • Optim™ insulation is a chemical co-polymer that offers superior handling and durability.3
  • 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.4
  • 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)
7120/60 Optim Ext/Ret Helix 7 Dual-coil True bipolar 17 DF1; IS-1 60
7120/65 Optim Ext/Ret Helix 7 Dual-coil True bipolar 17 DF1; IS-1 65
7120Q/52 Optim Ext/Ret Helix 7 Dual-coil True bipolar 17 DF4 52
7120Q/58 Optim Ext/Ret Helix 7 Dual-coil True bipolar 17 DF4 58*
7120Q/65 Optim Ext/Ret Helix 7 Dual-coil True bipolar 17 DF4 65*
7121/60 Optim Ext/Ret Helix 7 Dual-coil True bipolar 21 DF1; IS-1 60
7121/65 Optim Ext/Ret Helix 7 Dual-coil True bipolar 21 DF1; IS-1 65
7121/75 Optim Ext/Ret Helix 7 Dual-coil True bipolar 21 DF1; IS-1 75
7121Q/52 Optim Ext/Ret Helix 7 Dual-coil True bipolar 21 DF4 52
7121Q/58 Optim Ext/Ret Helix 7 Dual-coil True bipolar 21 DF4 58
7121Q/65 Optim Ext/Ret Helix 7 Dual-coil True bipolar 21 DF4 65
7122/60 Optim Ext/Ret Helix 7 Single-coil True bipolar N/A DF1; IS-1 60
7122/65 Optim Ext/Ret Helix 7 Single-coil True bipolar N/A DF1; IS-1 65
7122/75 Optim Ext/Ret Helix 7 Single-coil True bipolar N/A DF1; IS-1 75
7122Q/52 Optim Ext/Ret Helix 7 Single-coil True bipolar N/A DF4 52
7122Q/58 Optim Ext/Ret Helix 7 Single-coil True bipolar N/A DF4 58*
7122Q/65 Optim Ext/Ret Helix 7 Single-coil True bipolar N/A DF4 65*
7170/60 Optim Tines 7 Dual-coil True bipolar 17 DF1; IS-1 60
7170/65 Optim Tines 7 Dual-coil True bipolar 17 DF1; IS-1 65
7170/75 Optim Tines 7 Dual-coil True bipolar 17 DF1; IS-1 75
7170Q/52 Optim Tines 7 Dual-coil True bipolar 17 DF4 52
7170Q/58 Optim Tines 7 Dual-coil True bipolar 17 DF4 58
7170Q/65 Optim Tines 7 Dual-coil True bipolar 17 DF4 65
7171/60 Optim Tines 7 Dual-coil True bipolar 21 DF1; IS-1 60
7171/65 Optim Tines 7 Dual-coil True bipolar 21 DF1; IS-1 65
7171/75 Optim Tines 7 Dual-coil True bipolar 21 DF1; IS-1 75
7171Q/52 Optim Tines 7 Dual-coil True bipolar 21 DF4 52
7171Q/58 Optim Tines 7 Dual-coil True bipolar 21 DF4 58
7171Q/65 Optim Tines 7 Dual-coil True bipolar 21 DF4 65
7172Q/52 Optim Tines 7 Single-coil True bipolar N/A DF4 52
7172Q/58 Optim Tines 7 Single-coil True bipolar N/A DF4 58
7172Q/65 Optim Tines 7 Single-coil True bipolar N/A DF4 65
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*Indicates lead lengths that are MRI Conditional1,2

1. MRI Conditional Field Strength, 1,5 Tesla

2. See MRI Procedure Information for approved MR Conditional Systems Device/Lead combinations and scan parameters

3. 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).

4. 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. Devices depicted may not be available in all countries. Check with your St. Jude Medical representative for product availability in your country.

 

Indications for Use: The Durata™ 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. A transvenous lead system may offer the patient the benefit of avoiding a thoracotomy for lead implantation. If the initial lead configuration is not effective, repositioning of the lead or other lead configurations should be attempted. In some patients, a nonthoracotomy lead configuration may not provide reliable conversion of arrhythmias, and the use of subcutaneous or epicardial patch defibrillation leads should be considered.

Contraindications: Contraindications for use of the Durata leads with an implantable pulse generator include ventricular tachyarrhythmias resulting from transient or reversible factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction. Transvenous lead systems are contraindicated for patients with tricuspid valvular disease or a mechanical heart valve. Durata leads are contraindicated for patients for whom a single dose of 1.0 mg of dexamethasone sodium phosphate is contraindicated. The Durata leads are contraindicated for extra firm (red color knob) stylets. The lead is not designed, sold, or intended for use other than as indicated. 1. St. Jude Medical™ DF1 lead connectors conform to the international connector standard ISO 11318/Amd. 2. St. Jude Medical IS-1 lead connectors conform to the international connector standard ISO 5841. 3. St. Jude Medical DF4 lead connectors conform to the international connector standard ISO 27186: 2010 (E).

 

Potential Complications: Possible complications of the use of transvenous lead systems include, but are not limited to, supraventricular or ventricular arrhythmias, conduction disturbances, cardiac perforation, cardiac tamponade, loss of contractility, air embolism, heart wall rupture, myocarditis, post-operative heart failure, chronic mechanical stimulation of the heart, tricuspid valve dysfunction, lead fracture necessitating surgical removal, pneumothorax, hemothorax, infection, tissue necrosis and erosion of the skin. Specific events and effects are summarised below:

 

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

SJM-DUR-1114-0001(1)

Last Updated: January 02, 2019

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