FDA approves Thoratec's HeartMate II as a "destination therapy"

January 20, 2010 by MassDevice staff

The Food & Drug Administration cleared Thoratec Corp.'s HeartMate II left ventricular assist device for use in patients with severe heart failure who aren't eligible for a transplant.

The U.S. Food & Drug Administration expanded its clearance of Thoratec Corp.'s (NSDQ:THOR) HeartMate II left ventricular assist device for implantation into patients who can't receive heart transplants.

The federal watchdog agency had previously cleared the device, which helps the heart's pumping action in patients with severe heart disease, for use in people waiting for a heart transplant. The expansion means the device can be used as a so-called "destination therapy," implanted indefinitely in people who aren't eligible for a new heart.

A randomized clinical study of 134 patients found that 46 percent were still living two years after implantation with the HeartMate II, with no disabling stroke or the need for device replacement or repair. Eleven percent of the 66-patient control group showed the same end results. Data from a separate registry of smaller-stature women and men indicated that the device worked well in that population.

The FDA is requiring Thoratec to conduct a post-approval study evaluating the device's performance, with the data to be made available in the Interagency Registry of Mechanical Assisted Circulatory Support when the post-approval study is concluded.

Pleasanton, Calif.-based Thoratec posted third-quarter sales of $87.9 million during the three months ended Oct. 3, 2009, up 8.8 percent compared with $80.8 million during the same period in the prior year. Net income soared 94.4 percent to $11.8 million, compared with $6.1 million during Q3 2008.

The FDA decision keeps Thoratec one step ahead of its nearest competitor, Framingham, Mass.-based HeartWare International Inc. (NSDQ:HTWR), which applied for an investigational device exemption for its own LVAD as a destination therapy in November, 2009.