Boston Scientific has received Conformité Européenne (CE) Mark for its Confient implantable cardioverter defibrillator (ICD).
The approval represents the first Boston Scientific-branded cardiac rhythm management device to treat sudden cardiac death, according to the Natick, Mass.-based manufacturer. Sudden cardiac death is an abrupt loss of the heart function, usually due to an electrical rhythm dysfunction in the lower chambers of the heart.
The Confient ICD is designed to reduce right ventricular pacing, and contains wireless capability, according to Boston Scientific.
Boston Scientific markets other implantable defibrillators, which became property of the company through its buyout of the Indianapolis-based Guidant in 2006.
The Confient ICD is not currently available for sale in the United States.