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.
HeartWare is conducting an international trial for the device involving five investigational centers in Europe and Australia. More than 40 patients have been enrolled in that trial to date.
The U.S. trial will enroll 150 patients awaiting heart transplantation at up to 28 centers. Leslie Miller, MD, is the trial's principal investigator at WHC. The company reported receiving FDA approval for an Investigational Device Exemption for its LVAS earlier this year (Medical Device Daily, May 13, 2008).
Godshall estimated that the trial would take somewhere between 15 and 24 months to complete enrollment, but said that the exact timing is hard to gauge because only one patient at one center has been enrolled so far. So it may be a while before the HeartWare LVAS is on the U.S. market, though Godshall jokingly said he would like to file for FDA approval today, having just one patient enrolled in the U.S. trial, but he doubted the agency would go for that.
"We expect a number of additional centers to complete their internal review processes and to begin enrolling patients over the next several months," he said.
In addition to the pump's small size, Godshall said the system has a long battery life, is easy for the patient to use, easy for the doctor to implant, and the impeller that spins inside the pump is suspended by magnetic forces, eliminating the use of mechanical bearings, which means the system should be more durable.
While these types of devices are usually called a Left Ventricular Assist Device (LVAD), HeartWare was careful to call its system an LVAS, rather than an LVAD.
"The industry is slowly trying to move to make sure people know this is not just a pump ... it's a whole system," Godshall said.
The HeartWare LVAS has been in development for the better part of 10 years, Godshall said, and the early developers and advisors of the company were looking for "an extremely easy and reproducible implant procedure, pericardial placement that avoided abdominal surgery and a pump pocket ... and a durable impeller suspension system."
According to a company statement, the surgery at WHS was "quick and without incident and the patient is recovering well."
"Like many of our colleagues, we have been closely watching HeartWare's progress and have been impressed by the results from the international clinical trial," Miller and Boyce said in a joint statement.
Godshall called the start of HeartWare's U.S. trial "one of the most important milestones in the company's history."
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 (MDD, Dec. 4, 2007).