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EU OKs Boston Scientific Device

Its Confient implantable cardioverter defibrillator gets European regulatory approval.

Boston Scientific

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received CE Mark approval for its Confient implantable cardioverter defibrillator (ICD), a cardiac rhythm management device that treats sudden cardiac death (SCD), or the abrupt loss of heart function.

SCD is usually due to an electrical rhythm dysfunction in the lower chambers of the heart, called ventricular fibrillation. An ICD is a small implantable device placed under the skin just below the collarbone that uses wires threaded into the heart's chambers to monitor each heartbeat. If a potentially deadly rhythm is detected, a shock is delivered, restoring normal heart rhythm and preventing sudden cardiac death.

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Boston Scientific, which entered the implantable heart defibrillator business with the purchase of Guidant last year, said that each year SCD claims the lives of as many as 350,000 people in Europe, and that more people die from it each year than from lung cancer, breast cancer and AIDS combined.

The Confient ICD is not available in the U.S.

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