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Heart-Assist System Approved for Severe Heart Failure
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WEDNESDAY, Jan. 20 (HealthDay News) -- A device that helps the heart's left ventricle pump blood in people who have severe heart failure but who aren't candidates for heart transplant has been approved by the U.S. Food and Drug Administration.
The HeartMate II is already FDA-approved for people awaiting heart transplant and other "complex" forms of treatment, the agency said in a news release.
The heart-assist device is a small mechanical pump that's surgically implanted just below the heart. A cable that powers the pump passes through the user's skin to a controller that's worn around the wrist. A physician has the ability to program the pump's speed, based on the user's needs, the FDA said.
As a condition of approval, the California-based device maker, Thoratec Corp., will conduct an additional clinical study to further evaluate the device's performance, the agency said.
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