HeartWare International Inc. (NSDQ:HTWR) won a pair of approvals from the Food & Drug Administration for clinical trials of its cardiac assist device.
The Framingham, Mass.-based medical device maker said the FDA granted an investigational device exemption supplement for its Advance bridge-to transplant trial for an additional 54 patients.
It’s the second time the FDA has allowed HeartWare to expand the trial. In April, the federal watchdogs granted a first, 54-patient IDE supplement for the 140-subject trial, which is testing the company’s ventricular assist device for patients who are waiting for a heart transplant. HeartWare said the last patient from the first expansion was implanted with its HVAD device in August.
The company also said it expects to file for pre-market approval of the device for a bridge-to-transplant indication in December.
The FDA also granted full approval for enrollment in HeartWare’s Endurance destination therapy trial, after initially clearing the study in June. HeartWare said the study is designed to study the use of the HVAD device in 450 patients with advanced heart failure who can’t receive heart transplants.
HeartWare posted a $9.9 million loss on $9.7 million in sales for the three months ended June 30, compared to a $6.9 million loss on $1.4 million in sales during the second quarter of 2009.
