A new heart-pumping device worked significantly better in heart-failure patients who were ineligible for a heart transplant than an older, approved device, according to a study released Tuesday.

The study, presented to doctors during a late-breaking clinical-trials session at the American Heart Association's annual meeting, compared two devices made by Thoratec Corp. (THOR) of Pleasanton, Calif. The study was also published online in the New England Journal of Medicine.

One device, the HeartMate II, was approved last year for use in heart-failure patients who are awaiting heart transplants. However, the company is hoping the U.S. Food and Drug Administration will grant the device wider approval for use in patients with advanced heart failure who won't get heart transplants.

An older device, HeartMate XVE, is approved for use in heart-failure patients who aren't candidates for heart transplants, but the device 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 version is about seven times smaller and is almost silent, researchers said.

Overall, the study showed patients who received the newer HeartMate device lived longer with fewer complications than patients being treated with the older device.

One of the study's authors, Joseph G. Rogers of Duke University in Durham, N.C., explained that the older device isn't widely used and the newer device is currently limited to a relatively small group of patients who are awaiting heart transplants.

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 study of the heart-pumping devices involved 200 patients, of whom 134 were implanted with the newer device and 66 with the older device, in order to compare the effectiveness of the products. Each product pumps in a different manner, but are both are designed to help a damaged heart properly pump blood. The devices are implanted in the body and are powered by a battery pack worn outside the body.

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.

Rogers explained that patients receiving the devices are among the most severe heart-failure patients who often have less than a year to live. He said he hopes to be able to study patients at an earlier stage of heart failure to see if they would benefit from the device. The National Institutes of Health is currently seeking proposals from researchers to conduct such a study, but hasn't yet made a decision on which proposals to fund.

Looking at just survival, 68% of patients with the newer HeartMate 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 study was funded by Thoratec. Rogers has served as a company consultant.

Thoratec shares were recently trading at $30.74, up $2.66, or 9.5%

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

(Jon Kamp contributed to this article.)
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