Framingham, Mass.-based cardiac device maker HeartWare International (NSDQ:HTWR) won FDA premarket approval for its HeartWare ventricular assist system as a bridge to heart transplantation.
The HeartWare system includes an implantable pump, external driver and power source that can be used either inside or outside of hospitals, the FDA noted.
"For patients awaiting a donor heart, the HeartWare System provides a new treatment option," FDA Center for Devices & Radiological Health director Christy Foreman said in prepared remarks.
HeartWare representatives did not immediately return requests for comment.
Where other devices require pump components be placed in the abdomen, the HeartWare system fits in a small implant near the heart, which makes the device an option for smaller patients or those unable to have an implant in the abdomen, according to the federal watchdog agency.
"The FDA approved the HeartWare LVAD based on data from a clinical trial known as the ADVANCE trial," according to the agency notice. "The trial compared outcomes from 137 advanced heart failure participants using the HeartWare System with outcomes from similar patients followed by the Interagency Registry for Mechanically Assisted Circulatory Support."
This marks the 1st time the FDA has approved a left ventricular assist device based on clinical trials that relied on data as a control, the FDA noted.
HeartWare last month backed out of its REVIVE-IT study assessing the LVAD system in less-sick patients. HeartWare had contributed $600,000 to the study, and the company said at the time that it needed to focus efforts on winning FDA approval for the device.
"Following the positive recommendation of the Circulatory System Devices Advisory Committee in the 2nd quarter, we have been focused on working with the FDA as it finalizes its review of our premarket approval application for U.S. commercialization of the HeartWare ventricular assist system as a bridge to heart transplantation," president & CEO Doug Godshall said at the time.
Godshall added that the company plans to launch the HeartWare system and HVAD pump all around the world.
Earlier this month HeartWare reported its Q3 earnings, reporting strong growth in sales but deeply widening losses.
