Durata. Defibrillation Lead

Transcription

1 Durata Defibrillation Lead

2 What the data has to say about Durata ICD leads. We share a mutual goal to reduce risk and improve patient outcomes by advancing the practice of medicine. Now allow us to share the data on Durata ICD lead technology. Together, let s take a moment and focus on the facts that define excellence in lead performance. To discuss the numbers in detail. And examine the evidence that adds clarity to the larger conversation. Moving forward with confidence. It s what happens when everyone speaks the same language.

3 Reduction in externalized conductor failure rates. 1 CLOSER To CeNTER The decreased inner coil and stylet lumen diameter allow the conductors to be more closely configured to the center of the lead body. This reduces tension on the conductors and, therefore, the risk of externalized conductors. 2 Optim InsulAtion Credit for the 50% increase in wall thickness goes to advanced Optim insulation. Exclusive to St. Jude Medical leads and at least 50 times more abrasion-resistant than silicone, 1 Optim insulation blends the biostability and flexibility of silicone with the durability, lubricity and abrasion resistance of polyurethane. Durata OPtim 7F 3 7F Diameter Durata is the world s only 7F ICD lead technology engineered to avoid venous occlusion in patients with multi-lead systems or patients with smaller vasculature.

4 More innovation. Zero comparison. Over 85% of Durata ICD lead components are newly designed. Upgraded components Lead Body Insulation Thickness Durata lead 50% increase in insulation thickness Lead Body Insulation Material Optim insulation (with greater than 50 times the abrasion resistance of silicone) over the silicone 1 Inner coil Design Single Coil Lead Body Design Distal Cable Termination at Electrodes Shock Coils Connectors Cable Conductors Distal tip RV Shock Coil Smaller inner lumen positions cables closer to central axis, reducing shear stress and cable tension Additional conductor pair added to more evenly distribute force on cables. Maintains consistency with dual coil design Process technology change allowing cables to reside in a neutral stress state Flat wire shock coils, backfilled with silicone, minimize internal cable pressure against silicone insulation under shock coils, reducing risk of internal shorts DF4 connector added. Full Optim insulation also added to IS1, DF1 and DF4 connector tails Low Titanium (LT) grade material reduces impurities, providing higher fatigue strength Atraumatic soft silicone rubber tip to reduce tip pressure Curved slightly during manufacturing to create better buckle point Legacy Components Use of PTFE Use of ETFE Insulation tubing over inner coil for helix performance and insulation integrity Insulation coating over each cable for insulation integrity

5 600,000 Durata ICD leads: Better performance from the inside out. >500, ,000 Relative to first-generation 8F silicone ICD options, Durata 7F ICD leads with Optim insulation demonstrate 100% reduction in externalized conductor failure rates. The data also shows a 96% decrease in all-cause abrasion failures as well as a 99% reduction in internal shorts between the cable and shock coil. Finally, lead-to-can abrasions have diminished by 97% ,000 THEN product performance report data 1 riata lead Durata lead 97% Reduction in ALL-CAUSE ABRASION 3 92% Reduction in ALL-CAUSE Mechanical Failures 4 NOW active registry data at 5 years % Freedom from ALL-CAUSE ABRASION % Freedom from ALL-CAUSE MECHANICAL FAILURES 6 Cycles to Failure per unit (Mil) of Insulation 1 Optim Insulation 9,976 Silicone 300, , ,000 0

6 All Cause Internal Shorts (Reported cases and percentage) % 0.003% 0% 0.010% 0.020% 0.030% 0.040% 0.050% 0.060% 0.070% 0.080% 0.090% 0.100% Internal Shorts Under Shock Coil (Reported cases and percentage) % 0.001% 0% 0.010% 0.020% 0.030% 0.040% 0.050% 0.060% 0.070% 0.080% 0.090% 0.100% Lead-to-Can Abrasion % 0.01% 0%.2% 0.4% 0.6% 0.8% 1.0% Legend: Riata 8F Silicone Leads (156,308 Sold worldwide) Durata Leads (276,021 Sold worldwide) ICD lead technology cannot be insulated from change. The fact is, the Durata ICD lead is a significant step forward from earlier generation silicone-insulated options. Today, over 85% of Durata ICD lead components are newly designed and have resulted in improvements in abrasion resistance, elimination of externalized conductors and reductions in shorting under the shocking coils small but significant configuration changes that deliver dependable results and long-term durability.

7 Patients over 5 years An ICD lead study without equal. Over five years ago, we set out to actively monitor the post-market performance of all St. Jude Medical Optim -insulated leads. To ensure the most robust, long-term data and greatest amount of immediate transparency, thousands of patients were enrolled in the registries creating far and away the largest data-set of its kind. The results illustrate the level of precision and understanding that more than 27,000 patient-years of surveillance has to offer.

8 With more than 10,000 leads significantly more than that of the next closest competitive ICD lead study enrolled in post-market registries spanning more than a 60-month period, Optim ICD leads continue to show outstanding performance. Registries and Studies Launched/Follow-up Optim Leads Implanted Number of Sites OPTIMUM August 2006 > 5½ yrs 5,997 Durata and Riata ST Optim 224 SCORE September 2007 > 4½ yrs 3,458 Durata and Riata ST Optim 58 SJ4 PAS June 2009 >2½ yrs 1,743 Durata DF4 58 TOTALS 10,

9 100% 99.59% 98.71% 98.06% Lead Survival Probability 90% 80% Riata ST Optim/Durata Sprint Quattro secure Endotak Reliance G Medtronic System Longevity Study (SLS) Data: Medtronic CRDM Product Performance Report St. Jude Medical SCORE registry, OPTIMUM registry and SJ4 Post Approval Study Boston Scientific Longitudinal Surveillance Registry Years from Implant We don t manufacture claims. We equip you with facts. Take a closer look at how other prospective, active ICD lead registries measure up. The data on Durata ICD leads is clear. The overall survivability of St. Jude Medical ICD leads with Optim insulation compares favorably to Medtronic and Boston Scientific ICD leads. Dive deeper into the discussion at

10 References 1 Jenney C, Tan J, Karicherla A, Burke J, Helland J. A New Insulation Material for Cardiac Leads with Potential for Improved Performance, HRS 2005, Heart Rhythm, 2, S318-S319 (2005). 2 Based on complaints and returns through February 29, Based on returns and complaints analysis through February Based on returns and complaints analysis through December 2011, as reported in PPR. 5 While passive complaint reporting such as those in the product performance report (PPR) may underestimate the true failure rate associated with any given failure mechanisms, using returns and complaints analysis from the PPR helps to compare performance across lead families from one company. In contrast, data from actively monitored registries gathered by dedicated field monitoring represents the true commercial experience. 6 Data collected from SCORE, OPTIMUM, and SJ4 registries through December Global Headquarters One St. Jude Medical Drive St. Paul, Minnesota USA Fax Atrial Fibrillation Division One St. Jude Medical Drive St. Paul, Minnesota USA Fax U.S. Division 6300 Bee Cave Road Building Two, Suite 100 Austin, Texas USA Fax St. Jude Medical Coordination Center BVBA The Corporate Village Avenue Da Vinci Iaan, 11 - Box F1 B Zaventem Belgium Fax St. Jude Medical Brasil, Ltda. Rua Frei, Caneca A-CJ91/92 Sao Paulo - SP - Brasil CEP Fax St. Jude Medical (Hong Kong) Limited Suite 1608, 16/F Exchange Tower 33 Wang Chiu Road Kowloon Bay, Kowloon Hong Kong SAR Fax Rx Only Brief Summary: Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Riata, Durata, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies St. Jude Medical. All rights reserved. Item No: N01131