Framingham-based medical device manufacturer HeartWare International Inc. has applied for pre-market approval of a system that keeps patients who are waiting for a heart transplant alive.
The company completed a two-year advanced study of the HeartWare Ventricular Assist System in August, which was performed at 30 hospitals around the country with 140 patients.
The company, which makes miniature implantable heart pumps, has already received European Union approval for the system and is now awaiting pre-market approval from the U.S. Food and Drug Administration.
