HeartWare files for destination therapy IDE

November 23, 2009 by MassDevice staff

HeartWare International Inc. filed for an investigational device exemption from the Food & Drug Administration, seeking clearance for its miniature heart pump to be used as a destination therapy for end-stage heart failure patients who can't get transplants.

HeartWare International Inc. (NASDAQ:HTWR) took another step in its chase after one-time suitor and main competitor Thoratec Corp. (NSDQ:THOR), filing for an investigational device exemption from the Food & Drug Administration for clearance to use its miniature heart pump in patients with end-stage heart failure who aren't eligible for a heart transplant.

The Framingham, Mass.-based device maker's left ventricular assist device is already cleared for use as a bridge to heart transplant. The new application seeks an IDE for use of the device as a "destination therapy," in effect a permanent implant patients would carry until death.

HeartWare said it plans to conduct a study comparing its device with other FDA-approved destination therapy LVADs. The study would examine the rate of stroke in patients for two years after implantation, overall survival rates after two years, the incidence of adverse events during that time, patients' neuro-cognitive status and quality of life.

The FDA must still respond to HeartWare's proposal, a give-and-take process that takes place in 30-day cycles. The answer likely can't come soon enough for HeartWare as it looks to catch up with Thoratec. A recent study showed that Thoratec's HeartMate II device was effective as a destination therapy compare with its older HeartMate XVE LVAD. A spokesman for the Pleasanton, Calif.-based company told MassDevice it's already filed for pre-market approval from the FDA for the HeartMate II as a destination therapy.

HeartWare posted third-quarter sales of $3.4 million during the three months ended Sept. 30, up 14.6 percent compared with the prior quarter (the company began limited sales late last year, meaning a comparison of year-over-year results is misleading). HeartWare significantly narrowed both its operating and net losses during the quarter, compared with the previous three months. It cut operating losses by roughly 41 percent, to $3.4 million from $5.8 million during the June quarter. Net losses, meanwhile, declined to $5.9 million from $6.8 million, a 16 percent improvement over the prior quarter.