HeartWare (Farmingham, Massachusetts/Sydney, Australia) said that the first U.S. patient has received its HeartWare Left Ventricular Assist System (LVAS) at Washington Hospital Center (WHC; Washington), which marks the start of HeartWare's U.S. bridge-to-transplant clinical trial. Steven Boyce, MD, surgical director of the heart failure program at WHC, performed the surgery.
"Of course we think it's the best thing in the world, but we're a little biased," HeartWare's President/CEO Doug Godshall said, before telling Medical Device Daily what sets the HeartWare LVAS apart from others on the market. "What physicians seem to like about our product is it is a particularly small pump, about 50 ccs."
The pump is small enough to fit in the pericardial space adjacent to the heart, Godshall said, which avoids any abdominal surgery and having to create a pump pocket, which sometimes leads to infections. In the company's international trial of the product there have not been any implant infections, he added.
Other companies developing similar devices include Ventracor (Chatswood, Australia), Abiomed (Danvers, Massachusetts) and Thoratec (Pleasanton, California).
Ventracor offers the VentraAssist, a VAD that operates on a hemodynamically-suspended titanium impeller. The VentraAssist has a CE mark, and is currently enrolling patients in a U.S. pivotal trial (MDD, Sept. 19, 2007).
Abiomed makes the Impella 2.5, which installs percutaneously and straddles the aortic valve to drive blood from the left ventricle to the left atrium. In June, Abiomed received 510(k) clearance from the FDA for the Impella 2.5 as a circulatory support tool that interventionalists can use to increase blood flow to the heart muscle and vital organs. The company is also studying the device as an LVAD for heart attack patients (MDD, June 3, 2008).
Thoratec won an approvable recommendation with conditions from the circulatory systems advisory panel of the FDA late last year for its HeartMate II, the newest generation of the HeartMate LVAD.
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