Boston Scientific heart devices approved in Europe

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Boston Scientific has received CE Mark approval for its Cognis cardiac resynchronization therapy defibrillator (CRT-D) and Teligen implantable cardioverter defibrillator (ICD).

The devices are small and thin at 32.5 cc and 31.5 cc respectively, while less than 10 mm thick, according to the Natick, Mass.-based company. Both devices offer features based on engineering advances, including extended battery longevity, self-correcting software and programming technology. Boston Scientific also said that both devices also offer SafetyCore, a feature that in the unlikely event of a system error provides lifesaving shock therapy and basic pacing functionality.

The first Cognis and Teligen implants are scheduled to take place early next month, according to Boston Scientific. The company said it plans to build to a full launch in Europe and other international markets in the second quarter.

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