(RxWiki News) A U.S. Food and Drug Administration panel has recommended approval of HeartWare's Ventricular Assist System, which acts as a bridge to heart transplantation in end-stage heart failure patients.
The FDA Circulatory System Devices Advisory Committee's 9-2 decision that the system's benefits outweigh the risks means it must still be approved by the FDA. FDA officials often follow a panel's recommendation, but they are not required to make an approval.
"Ask your cardiologist about treatment options for advanced heart failure."
Doug Godshall, CEO and president of HeartWare, said they were pleased with the recommendation and look forward to future dialogue with the FDA as its review is finalized.
The miniaturized circulatory support device, or mechanical heart pump, was designed for patients with advanced heart failure awaiting heart transplantation or as destination therapy in those who are not eligible for a transplant.
The device is implanted next to the heart, skipping the abdominal surgery usually required to implant such devices. The ventricular assist system already is approved in the European Union and Australia.
HeartWave's Premarket Approval application was submitted in December 2010 and was based on a review of data presented from its ADVANCE study.
"HeartWare remains committed to optimizing outcomes for patients with end-stage heart failure and looks forward to expanding the clinical experience for the device in the future," Godshall said.