Boston Scientific (BSX) Receives FDA Approval for COGNIS Cardiac Resynchronization Therapy Defibrillator and TELIGEN ICD

May 13, 2008 5:18 PM EDT

Boston Scientific Corporation (NYSE: BSX) announced U.S. Food and Drug Administration (FDA) approval of its COGNIS cardiac resynchronization therapy defibrillator (CRT-D) and TELIGEN(TM) implantable cardioverter defibrillator (ICD). These devices represent entirely new platforms to treat heart failure and sudden cardiac death and are the result of a multi-year research and development effort to provide physicians enhanced clinical options for their patients.

"COGNIS and TELIGEN are truly breakthrough technologies featuring significant engineering advances," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "These products are testaments to the revitalization of our CRM business and our strong product pipeline. With more than 10 worldwide regulatory approvals since the beginning of the year and several others planned, we are delivering enhanced therapy systems designed to meet clinician needs for safety, reliability and better patient outcomes."

The COGNIS CRT-D and the TELIGEN ICD are among the world's smallest and thinnest high-energy devices at 32.5 cc and 31.5 cc respectively, while less than 10 mm thick. Both devices offer features based on substantial engineering advances, including extended battery longevity over previous Company devices, self-correcting software and improved programming technology.[SM]

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