HeartWare International Inc. (NSDQ:HTWR) won approval from the Food & Drug Administration to begin enrolling patients in a clinical trial of its cardiac assist device as a so-called “destination therapy.”
The FDA granted the Framingham, Mass.-based firm an investigational device exemption for the 450-patient Endurance study, which will examine the suitability of HeartWare’s ventricular assist system as a final therapy for patients with end-stage heart failure who can’t have a heart transplant and haven’t responded to other therapies.
HeartWare said patients would be randomly selected to receive either its device or an alternative device that’s already been approved as a destination therapy, at a two-to-one ratio. The trial will track the patients to its primary two-year end point, “stroke-free survival,” and for another three years during a follow-up period. “Stroke-free survival” is defined as “alive on the originally implanted device, transplanted or explanted due to patient recovery,” according to a press release.
The company also said that 17 centers have been cleared to enroll patients in its Advance trial of the device as a bridge to transplant, taking the total number of sites participating to 24. Eleven patients have been implanted in that study since the new clearance. HeartWare said it expects to apply for pre-market approval from the FDA for that indication by the end of the year.
HeartWare, which drummed up $55 million in a stock placement in January, posted first-quarter sales of $10.7 million during the three months ended March 31, up 624.2 percent compared with $1.5 million during the same period last year. Net losses were $4.5 million, or 35 cents per share, compared with $6.2 million, or 70 cents per share, during Q1 2009.