Boston Scientific Corporation today announced U.S. Food and Drug Administration (FDA) approval of its COGNIS™ cardiac resynchronization therapy defibrillator (CRT-D) and TELIGEN™ 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."
"When prescribing a high-energy device, I often had to make trade-offs among device size, battery longevity and features," said Poul-Erik Bloch-Thomson, M.D., KAS Gentofte Hospital, University of Copenhagen, Hellerup, Denmark. "The COGNIS and TELIGEN devices eliminate those trade-offs without compromising therapy options."
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.
COGNIS and TELIGEN are built on entirely new platforms, including device hardware, software and programming interface. Both devices offer a redundant hardware system called SafetyCore™, which provides lifesaving shock therapy and basic pacing functionality in the unlikely event of a system error. The products employ digital signal processing and are equipped with increased levels of digital memory, enabling more patient data to be captured and used by clinicians.
Key features of the COGNIS CRT-D include:
-- SmartDelay™ -- quickly proposes programmable device settings, which
enables physicians to tailor individualized pacing therapy for their
-- Bi-V Trigger -- helps physicians manage heart failure patients with
frequent atrial arrhythmias.
-- Electronic Repositioning™ -- provides physicians with six
configurations for stimulating the left side of the heart even after
implant, which may help avoid an additional surgical procedure.
Key features of the TELIGEN ICD include:
-- Thinnest ICD device available in the world -- the small size and
physiologic shape are designed with patient comfort in mind.
-- Quick Convert™ -- provides the ability for patients to receive
pacing therapy for ventricular tachycardias.
-- Enhanced AV Search algorithm -- designed to minimize unnecessary right
ventricular pacing. This feature, now with an extendable AV delay out
to 400 milliseconds, provides physicians with additional flexibility to
tailor device programming for individual patient needs.
COGNIS and TELIGEN are designed to be used with the LATITUDE® Patient Management System. The Company intends to offer LATITUDE support for COGNIS and TELIGEN as soon as possible following FDA approval.
Posted May 16th,2008