|HeartWare is working to get its Ventricular Assist System approved as a destination therapy.--Courtesy of HeartWare|
For HeartWare International, use of its increasingly successful Ventricular Assist System as a bridge-to-transplant is not enough. The Framingham, MA, company ($HTWR) is rolling out a supplemental trial arm as part of its ongoing work to test the device as a destination therapy.
The company wants to conduct the trial as part of a new patient group for its ENDURANCE trial, which is now under way. Plans call for enrolling up to 286 patients in what is known as the supplemental cohort, who will receive the HeartWare implant, plus 143 control patients.
Plans call for following patients for a year after implant. Once data from the whole trial are ready, it will support the company's PMA application to use its Ventricular Assist System as a destination therapy--well beyond the bridge-to-transplant option that has had the FDA's signoff since late 2012. The company's ADVANCE study helped support this approval, and a post-approval study of the bridge-to-transplant option is ongoing.
An expanded approval will help HeartWare reach many more patients, and also substantially boost revenue. The company's Ventricular Assist System's success in the U.S. remains a good sign. HeartWare booked $50.8 million in revenue during its fiscal 2013 second-quarter, a 75% hike. And the trajectory seems to continue upward, despite an issue with a loose component that led to one death and some repairs.
- read the release