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Durata™ Defibrillation Lead

Designed For Durability In Even the Most Challenging Cases

The Durata Defibrillation Lead is a cardiac lead that offers high performance handling, more control at implant and a proven platform of long-term durability, which help physicians better manage the risks inherent in ICD therapy and improve patient outcomes. The Durata Defibrillation Lead platform offers:

  • Downsized to 7 F through improved conductor configuration without compromising insulation
  • Improved single coil lead design driving lead reliability
  • 50% increase in outer insulation thickness
  • 50x more abrasion resistance through the addition of Optim™ Insulation1

Research has shown that the Durata Defibrillation lead has experienced:

  • 99.8% abrasion free rate based on more than 6 years of data2
  • ~ 90% reduction in abrasion rates vs. SJM silicone leads2
  • Zero events of externalized conductors  
Durata Defibrillation Lead
Overview

Durata Defibrillation Lead Reliability

The Durata Defibrillation Lead has a proven structural design which utilizes a unique Optim™ Insulation material that demonstrates excellent long-term durability3 and its thin 7 F size that can better accommodate multiple leads in a single vessel. Individuals requiring multi-lead systems, lead replacement, or who have small or tortuous veins provide some of the greatest challenges for implanting and managing patients with ICD leads. The Durata lead was designed to address these and other challenges associated with even the most difficult cases at every step in the process.

Performance for the Long Term

  • Minimize lead abrasion with exclusive Optim Insulation, a unique hybrid of silicone and polyurethane, which increases flexibility and lubricity.1 Optim insulation also provides abrasion resistance to minimize the risk of lead-on-lead and lead-on-can abrasion in multi-lead systems.
  • Restrict tissue growth into shock coils with exclusive flat wire shock coils completely back filled with silicone.

Confidence at Implant

Navigate challenging anatomy - the 7 F Durata Lead is the smallest ICD lead available today and may:

  • Improve passage through crowded veins, as seen in patients requiring lead replacement
  • Provide more options for lead access in the smaller cephalic vein
  • Increase maneuverability in patients with small or tortuous veins
  • Accommodate multiple or pre-existing leads in a single vessel utilizing the lubricious and flexible handling of the Durata lead

St. Jude Medical ICD Lead Design Evolution

St. Jude Medical ICD Lead Design Evolution

The DF4 Connector Header Difference

The DF4 Connector Header has a single terminal pin connection that decreases chances of lead-to-port mismatch. Fewer connections and setscrews lessen complexity, and the improved terminal pin visibility is designed to encourage proper lead connection.


References

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 2005, 2:S318-S319 (2005).

2 Based on complaints and returns through August 31, 2012, as reported in 2012-2 PPR.

3 Epstein, A.E., Baker, J.H., Beau, S.L., Deering, T.F., Greenberg, S.M., Goldman, D.S. Performance of the St. Jude Medical Riata Leads, HeartRhythm (2008), doi: 10.1016/j.hrthm.2008.10.030.

Tech Specs

Durata®

Defibrillation Lead
Ordering Information   View Catalog   

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

Indications, Safety & Warnings
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Durata®

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 Durata® Models 7120, 7120Q, 7121, 7121Q, 7122, 7122Q, 7170, 7170Q, 7171, 7171Q and 7172Q 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 7120, 7120Q, 7121, 7121Q, 7122, 7122Q, 7170, 7170Q, 7171, 7171Q and 7172Q 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.

Last Updated: March 23, 2014