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Thoratec Gets European Okay for IVAD Heart Pump

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CHICAGO (Reuters) – Cardiovascular device maker Thoratec Corp. said on Monday it has received European marketing approval for the Thoratec IVAD, an implantable heart pump that helps support one or both chambers of the heart.

The device is a smaller, implantable version of its ventricular assist device (VAD), which typically rests outside the patient’s chest with tubes connected to the heart.

Both devices support heart function and blood flow in late-stage heart failure patients who are awaiting heart transplantation or recovering from open-heart surgery.

At less than a pound, the IVAD is the smallest commercially available implantable VAD device, the company said.

The approval follows a clinical trial involving 17 patients in Europe. A similar trial is currently under way in the United States, and the company hopes to seek U.S. regulatory approval later this year.

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