Boston Scientific gains EU approval for new defibrillators

30 January 2008

Boston Scientific Corporation has been awarded CE Mark approval for its Cognis cardiac resynchronization therapy defibrillator (CRT-D) and Teligen implantable cardioverter defibrillator (ICD) for treating heart failure and sudden cardiac death.

The new defibrillators are among the smallest and thinnest high-energy devices available, at 32.5 cc and 31.5 cc respectively, while less than 10 mm thick. Both devices offer features based on significant engineering advances, including 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.

Jim Tobin, President and Chief Executive Officer of Boston Scientific, said, "We have re-engineered the way we design, build, test and report on our technology. 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."

The first implants are scheduled to take place early next month. The company plans to build to a full launch in Europe and other international markets in the second quarter.

Both defibrillators are pending approval by the US Food and Drug Administration and are not available for sale in the United States.

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