NATICK, Mass., May 12 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX - News) today announced CE Mark and the first human implants of the Company’s ENDOTAK RELIANCE® 4-SITE defibrillation lead system. Defibrillation leads are insulated wires that connect an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) to the heart and, when needed, deliver life-saving therapy.
The ENDOTAK RELIANCE 4-SITE lead system is designed to simplify the implant procedure by combining three terminals into one integrated connector, reducing the required implant area within the body. This system, combined with the new TELIGEN® ICD and COGNIS® CRT-D, is designed to comply with the forthcoming international connector standard(1). The new standard will permit product compatibility across manufacturers. The Company is working with physicians to launch the system in several phases with a focus on monitoring clinical performance through robust post-market analysis enhanced by the LATITUDE® Patient Management system(2).
“We are pleased to announce CE Mark and the first human implants of the ENDOTAK RELIANCE 4-SITE lead system,” said Fred Colen, President, Boston Scientific Cardiac Rhythm Management. “This new system represents the next advance for the ENDOTAK RELIANCE lead family, which has demonstrated reliability in more than 350,000 implants worldwide.”
This technology allows the world’s smallest, thinnest high-energy ICDs and CRT-Ds to become even smaller. The connector reduces the volume of TELIGEN and COGNIS to 32 cc and 30 cc respectively, while maintaining a thickness of less than 10 mm.
Some models of the ENDOTAK RELIANCE 4-SITE product line feature a proprietary GORE(TM) covering designed to prevent tissue ingrowth into the defibrillation coils, without compromising the electrical performance of the lead. The ENDOTAK RELIANCE G model is the only defibrillation lead on the market to address tissue ingrowth using this innovative approach. Preventing tissue ingrowth assists physicians with the long-term management of device patients. Although rare, lead removal is sometimes necessary. Studies have shown that the proprietary covering helps physicians perform this procedure more easily and effectively.
The implants were performed under the leadership of the following physicians:
* Oliver Przibille, M.D., Cardioangiolisches Centrum Bethanien, Frankfurt, Germany * Hans-Joachim Trappe, M.D., Marienhospital Herne Klinikum der Ruhr-Universitat Bochum, Herne, Germany * Johannes Heintze, M.D., Herz und Diabeteszentrum Nordrhein-Westfalen Bad Oeynhausen, Bad Oeynhausen, Germany * Lieselot van Erven, M.D., Leiden University Medical Center, Leiden, The Netherlands
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.
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(1) International Organization for Standardization (ISO) IS-4/DF-4 standard.
(2) The LATITUDE Patient Management system is not yet approved in Europe.
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