May 13, 2008 - Boston Scientific reported that the FDA cleared its COGNIS cardiac resynchronization therapy defibrillator (CRT-D) and TELIGEN implantable cardioverter defibrillator (ICD), enabling the company to introduce new platforms to treat heart failure and sudden cardiac death.
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, designed to provide 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 the following:
- SmartDelay quickly proposes programmable device settings, which enables physicians to tailor individualized pacing therapy for their patients.
- 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 are:
- It is reportedly the Thinnest ICD device available.
- Quick Convert provides the ability for patients to receive pacing therapy for ventricular tachycardias.
- Enhanced AV Search algorithm is 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.
For more information: www.bostonscientific.com