January 22, 2008
BSX Heart Devices Clear Euro Requirement
By Matthew L. Brown
Two heart defibrillators made by Natick-based Boston Scientific Corp. have received CE Mark approval.
The CE mark indicates that the devices meet European legal conformity standards. Neither device has been approved by the U.S. Food and Drug Administration.
The defibrillators are the Cognis cardiac resynchronization therapy defibrillator and the Teligen implantable cardioverter defibrillator. The devices were designed to be small and lightweight with long battery life. The first devices are scheduled to be implanted in European patients next month.
The CE mark indicates that the devices meet European legal conformity standards. Neither device has been approved by the U.S. Food and Drug Administration.
The defibrillators are the Cognis cardiac resynchronization therapy defibrillator and the Teligen implantable cardioverter defibrillator. The devices were designed to be small and lightweight with long battery life. The first devices are scheduled to be implanted in European patients next month.
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