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HeartWare Wins U.S. Approval of Implantable Heart Pump

HeartWare International Inc. won U.S. regulatory approval for its implantable pump for heart-transplant candidates, providing a smaller device than the only so-called mechanical heart approved for patients in the country.

The company’s shares rose the most in seven months. HeartWare, which has marketed its product in Europe since 2009, is prepared to sell the device immediately in the 50 U.S. hospitals that participated in clinical studies, Doug Godshall, president and chief executive officer of the Framingham, Massachusetts-based company, said today in a statement.

HeartWare’s product, designed to support blood flow in people who have weakened hearts and are awaiting a transplant, will compete with Thoratec Corp.’s HeartMate II. HeartWare’s device is smaller, allowing it to be implanted in smaller patients, the Food and Drug Administration said in a statement.

“Its small size facilitates faster surgery and recovery times,” Michael Manns, a Bloomberg Industries analyst, said in a February research report.

HeartWare rose 9 percent to $89.54 at the close in New York, its biggest single-day gain since April 26. Thoratec, based in Pleasanton, California, fell 1.1 percent to $35.

Heart failure is a progressive disease that strikes 1 in 5 Americans older than 40. It occurs when a damaged organ can’t supply enough oxygen-rich blood to keep other organs, such as the lungs, working. There are few treatments and no cure.

Product Expansion

The pumps are intended to take over for a failing heart, extending patients’ lives or gaining time to find a transplant donor. Godshall said HeartWare will expand to more hospitals that undergo training.

Thoratec’s HeartMate generated $366 million in revenue last year, according to data compiled by Bloomberg. HeartMate II is approved for heart-failure patients whether they are eligible for transplantation.

HeartWare, which reported $83 million in revenue for 2011, is studying the device in 450 patients who aren’t transplant candidates, the company said in the statement. The final patients in the study were implanted in May and will be followed up for two years.

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