These “truly breakthrough” new ICDs from Boston Scientific have just been cleared by U.S. Food and Drug Administration.
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 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 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.
Press release: Boston Scientific Announces FDA Approval for New Devices to Treat Heart Failure and Sudden Cardiac Death…