NATICK, Mass., May 13 Boston ScientificCorporation (NYSE: BSX) today announced U.S. Food and Drug Administration(FDA) approval of its COGNIS(TM) cardiac resynchronization therapydefibrillator (CRT-D) and TELIGEN(TM) implantable cardioverter defibrillator(ICD). These devices represent entirely new platforms to treat heart failureand sudden cardiac death and are the result of a multi-year research anddevelopment effort to provide physicians enhanced clinical options for theirpatients.
"COGNIS and TELIGEN are truly breakthrough technologies featuringsignificant engineering advances," said Jim Tobin, President and ChiefExecutive Officer of Boston Scientific. "These products are testaments to therevitalization of our CRM business and our strong product pipeline. With morethan 10 worldwide regulatory approvals since the beginning of the year andseveral others planned, we are delivering enhanced therapy systems designed tomeet clinician needs for safety, reliability and better patient outcomes."
"When prescribing a high-energy device, I often had to make trade-offsamong device size, battery longevity and features," said Poul-ErikBloch-Thomson, M.D., KAS Gentofte Hospital, University of Copenhagen,Hellerup, Denmark. "The COGNIS and TELIGEN devices eliminate those trade-offswithout compromising therapy options."
The COGNIS CRT-D and the TELIGEN ICD are among the world's smallest andthinnest high-energy devices at 32.5 cc and 31.5 cc respectively, while lessthan 10 mm thick. Both devices offer features based on substantialengineering advances, including extended battery longevity over previousCompany devices, self-correcting software and improved programming technology.
COGNIS and TELIGEN are built on entirely new platforms, including devicehardware, software and programming interface. Both devices offer a redundanthardware system called SafetyCore(TM), which provides lifesaving shock therapyand basic pacing functionality in the unlikely event of a system error. Theproducts employ digital signal processing and are equipped with increasedlevels of digital memory, enabling more patient data to be captured and usedby clinicians.
COGNIS and TELIGEN are designed to be used with the LATITUDE(R) PatientManagement System. The Company intends to offer LATITUDE support for COGNISand TELIGEN as soon as possible following FDA approval.
Boston Scientific is a worldwide developer, manufacturer and marketer ofmedical devices whose products are used in a broad range of interventionalmedical specialties. For more information, please visit:www.bostonscientific.com.
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