World Heart trial shows Novacor LVAS extends life by factor of three

New York, Nov. 16 - World Heart Corp. said a study of its Novacor LVAS found it extended survival time by more than three times compared to control patients who received optimal medical therapy but no device.

In addition, patients who used the device scored significantly higher on standard measures of quality of life than patients in the control group.

The results of the Interpid study (Investigation of Non-Transplant Eligible Patients who are Inotrope Dependent) on patients with severe end-stage heart failure who are not eligible for a heart transplant were presented at the 2005 Scientific Sessions of the American Heart Association meeting in Dallas.

"Patients who received the devices not only had a lengthened quantity of life, but they appeared to have an improved quality of life," Duke University cardiologist Joseph Rogers, who presented the trial results, said in a news release.

"This is a remarkably ill group of patients, and when you look at the control group, which was receiving the best care medicine has to offer, we can only keep 10% of them alive after one year."

Two LVAS recipients from the Intrepid study are currently supported after more than four years, on their original devices.

"The study data is consistent with the world-wide Novacor experience," said Piet Jansen, WorldHeart's chief medical officer. "Patients on LVAS support commonly return to home and to work, leading normal, active lives. Individuals have been successfully supported for as long as six years."

Novacor LVAS is a pump implanted alongside the patient's own heart to take over a large portion of the workload of the natural heart.

WorldHeart is now conducting a pivotal randomized study comparing the Novacor LVAS to an approved destination therapy device with the goal of demonstrating that use of Novacor LVAS is superior to optimal medical therapy by demonstrating equivalence to the HeartMate XVE LVAS, which has been evaluated and approved for that use.

World Heart is an Oakland, Calif., maker of mechanical circulatorysupport systems.

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