HeartWare International Inc. (NSDQ:HTWR) filed a pre-market approval application with the Food & Drug Administration for its cardiac assist device.
The Framingham, Mass.-based company’s ventricular assist system is designed to provide a temporary "bridge" for heart transplant patients with "end-stage heart failure," according to the company.
Patients implanted with the device in HeartWare’s Advance clinical trial had a 94 percent survival rate, according to the company.
The company closed a $143.8 million debt offering and investor Apple Tree Partners completed the sell-off of 1 million shares for more than $81 per share in December.
A PMA is a regulatory pathway to market medical devices that have no incumbent products with which the FDA can compare the safety.
