FDA Okays Heart Pump as Permanent Implant; Reimbursement Decision Looms

Originally Published MDDI December 2002

NEWS & ANALYSIS

Maureen Kingsley

In a landmark decision made last month, FDA approved the HeartMate SNAP-VE left ventricular-assist system (VAS) for use in destination therapy for end-stage heart failure patients. HeartMate, manufactured by Thoratec Corp. (Pleasanton, CA), in addition to other VAS devices, had previously been approved by the agency only as so-called bridge-to-transplant devices for Class IV heart failure patients awaiting transplants. This November, however, Thoratec got the green light from FDA to market HeartMate as a permanent, lifesaving alternative to a heart transplant.

D. Keith Grossman, Thoratec's CEO, said he is generally satisfied with the amount of time FDA took to process the destination-therapy PMA supplement Thoratec filed in October of last year. "Our review time of 13 months was probably in-line with—or very close to—FDA averages," Grossman said. FDA had ordered an expedited review for this particular PMA supplement, and Thoratec had originally hoped for approval "around the middle of this year, no later than August or so," according to Grossman. "We were certainly a little bit disappointed in the delay beyond that point," he added. "But I think, in the big picture, [the timing is] in line with what you'd expect."

Thoratec estimates that of the roughly 500,000 heart failure patients who are designated Class IV each year, only about 2000 are matched with donor organs. That would leave hundreds of thousands of patients who could potentially benefit from VAS destination therapy. "If you look at those patients," Grossman said, "the question is, are they all candidates for destination therapy? And the answer is probably not today— but eventually, they will be."

With the FDA-approval hurdle negotiated, Thoratec eagerly awaits a reimbursement decision from CMS. Grossman doesn't seem too nervous. "We're very optimistic," he said. The REMATCH trial was "a blue-ribbon [clinical] trial run by the National Institutes of Health— extremely well run and controlled." He pointed out that the patient population positioned to benefit most from destination therapy currently has no alternative. It's a matter of survival, not quality of life, he said. "These patients die without it and live with it."

Furthermore, CMS does currently reimburse for HeartMate and other VAS devices as bridge-to-transplant systems. "There are no guarantees in this field," Grossman said, "but we came into this process with a high degree of confidence that we'll have reimbursement."

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