HeartWare: It'll Be a New Study for MVAD

HeartWare's next-generation left ventricular assist device MVAD, the subject of a CE Mark trial that was halted last fall, will be studied in a new trial once it is ready to return to the clinic.

MVAD, HeartWare’s next-generation left ventricular assist device (LVAD), isn’t yet ready to be studied again in humans, but when it is, expect a new study.

That was the message from HeartWare executives Wednesday on a conference call with analysts to discuss the company’s first quarter earnings results.

The new device has been a major focus for the company, as expectations for LVAD therapy, used in patients with severe heart failure, have risen in recent years. MVAD’s development hit a snag last fall when a trial—in which 11 patients had already been implanted—to support a CE Mark approval was halted because of pump clotting problems and issues with the pump’s suction function. At the time, 11 patients had been implanted in the trial.

There had been some question whether HeartWare would try to pick up where it left off with that CE Mark trial, or start over with a new study. HeartWare CEO Doug Godshall said that a new study would be “the most prudent path.” “You’ve got enough events in that cohort that you’d rather not burden your final study report with several events and try to explain them away,” he said, according to a Seeking Alpha transcript of the earnings call.

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A big question that has lingered as HeartWare works on MVAD is whether the pump will need a redesign or if less-sweeping changes will be sufficient. Godshall continued to say he doesn’t see the need for what he would term a redesign, such as making alterations to the pump’s impeller or blood path.

Godshall explained that a “very short list” of improvements are being considered and tested for MVAD and that “we’re 80% of the way towards certainty as to what we’re going to be selecting.” This testing is being done to determine that any changes don’t add complexity or have other unexpected effects. One of the key modifications being finalized is what he described as “an enhanced suction response.”

“We have held multiple reviews of our work product to date and it is clear our technical and clinical advisors are much more bullish now than they were just a couple of months ago,” Godshall said.

Bench testing and animal studies will need to be completed before MVAD is ready for humans again. When implants may resume is still not clear, but an update on timing is expected this year.

Wells Fargo analyst Larry Biegelsen wrote in a research note Wednesday that he believes it will be at least another year before human implants are started again for MVAD.

MVAD is just one of the company’s priorities. Its current generation device, HVAD, will be the subject of a PMA submission to FDA this summer for a destination therapy (DT) indication. DT is a term used for patients who aren’t expected to receive a heart transplant but will instead use an LVAD for the rest of their lives. Analysts and clinicians are eagerly awaiting clinical data from a supplement cohort of the HVAD DT trial for more insight into its performance in those patients. St. Jude Medical, which last year acquired HeartWare’s only commercial U.S. competitor, Thoratec, has had a DT indication for its LVAD for years.

Godshall remained upbeat about MVAD’s past challenges and future. “I think the first effort taught us a lot. And that, combined with the new enhanced testing we’re doing, should lead to the game changer kind of device that we’re all hoping and believing MVAD would be,” he said.