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
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.