WASHINGTON -- The FDA gave the green light on Tuesday for the HeartWare Ventricular Assist System as a bridge to heart transplantation in patients with heart failure.
The left ventricular assist device (LVAD) is a mechanical pump that helps those with end-stage heart failure pump oxygenated blood to the rest of the body.
There are several LVAD models approved for use as either a bridge-to-transplant or a permanent device, but this particular device, which weighs only 5 ounces, is compact enough that no parts need to be surgically implanted in the abdomen, according to the FDA press release.
The size also allows it to be used in smaller patients.
An FDA advisory committee overwhelmingly voted to recommend approval of the device in April. Although the panel was convinced about the device's efficacy (voting 11-0), certain members questioned its safety (voting 8-3).
A total of 11 patients receiving the HeartWare system had a stroke within 180 days of implantation, but whether 11 should be considered a high number was not clear, as researchers did not track stroke rates in the comparator registry (Interagency Registry for Mechanically Assisted Circulatory Support [INTERMACS]).
Panelists in favor of the device noted the alternative for these patients with end-stage heart failure is death if they cannot be bridged until a suitable donor heart is available.
The miniaturized device with an integrated inflow cannula is placed within the pericardial sac, avoiding the necessity of creating a pump pocket with its attendant infection risks, as well as simplifying the surgical insertion," said O.H. "Bud" Frazier, MD, of Texas Heart Institute, in a statement.
The device has been available in the European Union since 2009, and the company said it would begin an immediate commercial rollout in the U.S.
HeartWare is also seeking an indication as destination therapy for the system. The company said it has completed enrollment of a 450-patient destination therapy study at 50 U.S. sites. Results should be available in 2014.