PARIS, Sept. 24, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) has received regulatory approval to market the RELIANCE® 4-FRONT™ lead, its next generation implantable defibrillation lead now available in Europe and Asia. Defibrillation leads are insulated wires that connect an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator to the heart for treatment of heart failure and sudden cardiac arrest.
The RELIANCE 4-FRONT lead is built upon the demonstrated performance and reliability of the RELIANCE lead platform with design enhancements intended to simplify the implant procedure. With more than 350,000 implants worldwide, RELIANCE leads have demonstrated a 98.9 percent survival probability at 8 years 1.
"Leveraging the RELIANCE platform, we made a series of targeted design enhancements with RELIANCE 4-FRONT to improve and simplify implantation," said Kenneth Stein, M.D., chief medical officer of Boston Scientific's Cardiac Rhythm Management Group. "RELIANCE 4-FRONT represents our continued dedication to product innovation to meet the needs of patients and physicians."
Features of the new RELIANCE 4-FRONT lead include a modest size reduction in the lead body to improve handling and maneuverability while maintaining insulation thickness and reliability. IROX, a fractal coating, has been added to enhance electrical properties and lower pacing thresholds. The RELIANCE 4-FRONT lead also features a secured GORE™ coating, designed to prevent tissue ingrowth into the defibrillation coils. Adhering the GORE coating to the new lead simplifies implantation by eliminating steps in the current procedure.RELIANCE 4-FRONT is not available for sale in the United States. RELIANCE 4-FRONT in Asia In Asia, one of the world's fastest-growing ICD markets, the first two implants of the RELIANCE 4-FRONT lead were performed by Razali Bin Omar, M.D. and Azlan Hussin, M.D. at the Institute Jantung Negara Hospital in Kuala Lumpu, Malaysia.