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UPDATE: FDA Allows Wider Use Of Thoratec Heart-Pumping Device

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mlkrborn   Wednesday, 01/20/10 11:47:49 PM
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UPDATE: FDA Allows Wider Use Of Thoratec Heart-Pumping Device
Date : 01/20/2010 @ 4:54PM
Source : Dow Jones News
Stock : Thoratec Corp. (THOR)
Quote : 29.03 -0.49 (-1.66%) @ 7:58PM




UPDATE: FDA Allows Wider Use Of Thoratec Heart-Pumping Device

(Updated to add information on study used to support approval starting in sixth paragraph.)

By Jennifer Corbett Dooren

Of DOW JONES NEWSWIRES

WASHINGTON (Dow Jones)
The Food and Drug Administration Wednesday granted wider approval for a heart-pumping device made by Thoratec Corp. (THOR), allowing the device to be used in severely ill heart-failure patients who can't receive a heart transplant.

Until now the company's HeartMateII device had been approved for use in patients awaiting heart transplants.

The product, known as a left-ventricular assist device, is implanted inside the body and is designed to help the heart pump blood through the body. The device is run by an external battery pack that is worn around a patient's waist.

An older device, HeartMate XVE, is approved for use in heart-failure patients who aren't candidates for heart transplants, but is much larger than the newer device, and its pumping mechanism can be heard outside the body. The older HeartMate also can't be used in children or women. The new HeartMateII version is about seven times smaller and is almost silent.

The American Heart Association estimates that about 2,100 heart transplants are performed annually in the U.S., and that there are about 150,000 patients with advanced heart failure. In earlier stages of heart failure, patients are managed with medication or other devices such as defibrillators, but as the disease progresses there are few treatment options.

The approval was based on a study that compared patients receiving the HeartMateII device to patients receiving the older HeartMate XVE. The study involved 200 patients, of whom 134 were implanted with the newer device and 66 with the older device.

The main study goal looked at how many patients, after two years, remained free from a stroke or repeat surgery to replace or repair the device. After two years, 62, or 46%, of patients receiving the newer device reached the study goal, compared with 7, or 11%, of patients who received the older device.

Looking at just survival, 68% of patients with the newer device were alive one year after receiving the device, compared with 55% who received the older device. After the second year, 58% of patients with the new device were alive, compared with 24% of the patients with the older device.

The FDA said Thoratec
is being required to conduct a postapproval study to further evaluate the device's performance.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com




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