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Boston Scientific receives CE Mark approval for cardiac devices

Boston Scientific has announced CE Mark approval for its Cognis cardiac resynchronization therapy defibrillator and Teligen implantable cardioverter defibrillator.

These devices, according to the company, 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. Both devices are said to 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 in early February, 2008. The company plans to build to a full launch in Europe and other international markets in the second quarter.

Jim Tobin, president and CEO of Boston Scientific, said: “The Cognis CRT-D and the Teligen ICD are testaments to the revitalization of our CRM business and are just two of the many new products we plan to launch in 2008.”