Chris Delporte12.29.10
HeartWare International, Inc. has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its HeartWare Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure.
The HeartWare Ventricular Assist System features a small full-output circulatory support device designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices, according to company officials.HeartWare has received CE Marking for the HeartWare System in the European Union.The device currently is the subject of United States clinical trials for two indications: bridge-to-transplant under a continued access protocol and destination therapy.
The PMA submission includes data from HeartWare's ADVANCE clinical trial, an FDA-approved investigational device exemption study designed to evaluate the device as a bridge to heart transplantation for patients with end-stage heart failure.Under ADVANCE, 140 patients at 30 hospitals in the United States received the HeartWare between August 2008 and February this year.The last follow-up evaluation at 180 days was in August 2010.
According to the company, results for the trial showed that 92 percent of the investigational device patients met the per protocol primary endpoint of the trial, which was defined as alive on the originally implanted device, transplanted or explanted for recovery at 180 days. ADVANCE also demonstrated that 94 percent of the investigational device patients enrolled in the study achieved a survival endpoint at 180 days.
Framingham, Mass.-based HeartWare International (NASDAQ: HTWR) develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat Class IIIB/IV patients suffering from advanced heart failure. The company’s stock has more than doubled this year.
One of HeartWare’s major competitors is Danvers, Mass.-based Abiomed Inc., which makes the Impella heart pump. Earlier this month, Abiomed receive conditional FDA approval for a pilot study to test its Impella 2.5 device reducing heart muscle damage in patients with ST-elevation myocardial infarction.
The HeartWare Ventricular Assist System features a small full-output circulatory support device designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices, according to company officials.HeartWare has received CE Marking for the HeartWare System in the European Union.The device currently is the subject of United States clinical trials for two indications: bridge-to-transplant under a continued access protocol and destination therapy.
The PMA submission includes data from HeartWare's ADVANCE clinical trial, an FDA-approved investigational device exemption study designed to evaluate the device as a bridge to heart transplantation for patients with end-stage heart failure.Under ADVANCE, 140 patients at 30 hospitals in the United States received the HeartWare between August 2008 and February this year.The last follow-up evaluation at 180 days was in August 2010.
According to the company, results for the trial showed that 92 percent of the investigational device patients met the per protocol primary endpoint of the trial, which was defined as alive on the originally implanted device, transplanted or explanted for recovery at 180 days. ADVANCE also demonstrated that 94 percent of the investigational device patients enrolled in the study achieved a survival endpoint at 180 days.
Framingham, Mass.-based HeartWare International (NASDAQ: HTWR) develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat Class IIIB/IV patients suffering from advanced heart failure. The company’s stock has more than doubled this year.
One of HeartWare’s major competitors is Danvers, Mass.-based Abiomed Inc., which makes the Impella heart pump. Earlier this month, Abiomed receive conditional FDA approval for a pilot study to test its Impella 2.5 device reducing heart muscle damage in patients with ST-elevation myocardial infarction.