CE Granted for Boston Scientific’s New Defribrillator, ICD

 

January 22, 2008

January 22, 2008 - Boston Scientific Corp. today announced CE Mark approval for its COGNIS cardiac resynchronization therapy defibrillator (CRT-D) and TELIGEN implantable cardioverter defibrillator (ICD), representing entirely new platforms to treat heart failure and sudden cardiac death.

The high-energy devices are extrmely small and thin at 32.5 cc and 31.5 cc respectively, while less than 10 mm thick. Both devices offer extended battery longevity, self-correcting software and improved programming technology. Both devices also offer SafetyCore, a feature that in the unlikely event of a system error provides lifesaving shock therapy and basic pacing functionality.

Key features of the COGNIS CRT-D include the SmartDelay, which is designed to propose programmable device settings to enable physicians to tailor individualized pacing therapy for their patients. Bi-V Trigger is engineered for physicians to manage heart failure patients with frequent atrial arrhythmias. The electronic repositioning feature provides physicians with six configurations for stimulating the left side of the heart even after implant, which may help avoid an additional surgical procedure.

The TELIGEN ICD is a thin device designed with patient comfort in mind. Reverse Mode Switch is designed to eliminate unnecessary ventricular pacing. Quick Convert provides the ability for patients to receive pacing therapy for ventricular tachycardias.

The COGNIS CRT-D and the TELIGEN ICD are pending approval by the FDA and are not available for sale in the United States.

For more information: www.bostonscientific.com

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