Wednesday, February 15, 2012

HeartWare gets FDA meeting date for heart pump

By Patricia Resende, Correspondent

HeartWare International Inc. is one step closer to offering its heart pump to patients in the United States thanks to a date with the U.S. Food and Drug Administration.  

The Framingham-based medical device company announced it will meet with the FDA’s Circulatory System Device Panel in April in an effort to get the Premarket Approval (PMA) application of its left ventricular assisted devices. The news of the April 25 meeting pumped HeartWare’s shares up 2.4 percent at the close of business Tuesday.

HeartWare first submitted its Ventricular Assist System to the FDA in December 2010. The submission for approval by the FDA includes data from the company’s advance clinical trial, which is an FDA-approved study to review HeartWare’s system for use by patients with end-stage heart failure. During the study, a total of 140 patients at 30 hospitals in the nation received the device.

HeartWare’s meeting with the FDA shows progress in the company’s mission to prove that the pump is a safe bridge-to-transplant application for patients with end-stage heart failure, HeartWare CEO and President Doug Godshall said in a news release.

The company has received CE Marking for the system in the European Union and approval by Australia’s Therapeutic Goods Administration (TGA).

Califonia-based rival Thoratec Corp. also received a boost in shares after HeartWare’s announcement. Thoratec, which is awaiting news for is review before the panel, offered to pay $282 million for HeartWare in February 2009, but the deal came to screeching halt in July 2009 after the U.S. Federal Trade Commission said Thoratec was attempting to monopolize the left ventricular assist market.

The news comes less than two years after HeartWare completed its $144 million public offering of convertible senior notes and public offering of 1 million shares of its common stock, held by Apple Tree Partners.