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HeartWare wins premarket approval for its flagship implantable left ventricular assist device as a bridge to transplant for heart failure patients.

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Framingham, Mass.-based cardiac device maker HeartWare International (NSDQ:HTWR) won FDA premarket approval for its HeartWare ventricular assist system as a bridge to heart transplantation

The HeartWare system includes an implantable pump, external driver and power source that can be used either inside or outside of hospitals, the FDA noted.

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