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FDA weighs whether to approve Thoratec's Heart Mate II despite missed study goal


Associated Press Newswires (c) 2007. The Associated Press.

WASHINGTON (AP) - Government health advisers will consider Friday whether a mechanical heart pump from Thoratec Corp. should be approved, despite missing a key effectiveness goal in a company study.

Shares of the Pleasanton, Calif.-based Thoratec rose 80 cents, or 4.3 percent, Wednesday in midday trading.

The company has asked the Food and Drug Administration to approve the HeartMate II for heart-failure patients awaiting transplant. The battery-powered device is implanted in the chest, where it helps the heart's lower left chamber pump blood throughout the body. The new device is a smaller version of the company's original HeartMate model.

The FDA posted documents online Wednesday showing the Heart Mate II missed its effectiveness goal by one percentage point in a 126-patient study.

The device was considered effective if a patient survived 180 days after implantation or long enough to receive a heart transplant. The lower range of HeartMate's patient success rate was 64 percent, just under the 65 percent preset goal for effectiveness.

The FDA will ask its panel of outside cardiac experts "whether the results demonstrate a reasonable assurance of effectiveness even though the data did not meet the performance goal."

The agency is not required to follow the panel's recommendation, though it usually does.

The FDA will also question whether the device is safe and effective in smaller patients. Agency scientists noted in their review that Thoratec studied just 15 smaller-sized patients with the device, and only seven survived to meet the study's goal.

Despite concerns over effectiveness, several analysts say they expect a positive review of the device based on its safety profile.

"Safety matters more to the FDA than any other endpoint, and HeartMate II is clearly safer as well as more efficacious" than older devices, Lehman Bros. analyst Bob Hopkins wrote in a note Wednesday. Hopkins estimates the likelihood of a positive panel review at 90 percent.

Thoratec's competitors in heart devices include Oakland, Calif.-based World Heart Corp. and Australia-based Ventracor.



Thoratec Heart Pump Helped Most Patients, U.S. Finds

November 28 (Bloomberg) -- Thoratec Corp.'s experimental heart pump helped more than two-thirds of patients survive while awaiting a transplant, according to U.S. regulators. Thoratec rose the most in almost four months on the Nasdaq Stock Market.

Many patients experienced bleeding and infections, a common complication with the implanted device that may diminish as doctors use it more often, the staff of the Food and Drug Administration said in documents posted today on its Web site.

Thoratec's HeartMate II, smaller than a D-cell battery, is more compact than competing devices. A panel of outside advisers to the FDA is set to review the company's application for clearance of the HeartMate II in two days. If approved, the device will need additional studies after it is on the market, the FDA staff said.

``Doctors seem to want to use the device and believe it's the best option right now,'' said Joshua Zable, an analyst at Natixis Bleichroeder Inc. in New York, by telephone. ``HeartMate II still seems like the best option for patients. That's why investors believe FDA will ultimately approve the device, although they will likely approve it with follow-up attached.''

Thoratec rose 87 cents, or 4.7 percent, to $19.37 at 12:41 p.m. New York time in composite trading. The stock earlier touched $19.80, the most since Aug. 8. Thoratec, based in Pleasanton, California, climbed 23 percent in the 12 months before today.

Missed Goal

The study didn't meet its main goal of keeping at least 65 percent of patients alive for six months while they awaited a transplant. Twenty-nine percent of patients needed new operations because of bleeding.

By March 16, when the study was designed to end, 23 percent of 126 patients had died, mostly because of sepsis or neurological causes, according to the documents. Five patients who were followed through to September and who were originally not counted as successes were able to get transplants or were taken off the device because their hearts recovered, staff said.

Sixty-six of the 126 study participants had received a transplant and 15 survived six months while waiting, while 25 patients died. When researchers followed the patients through Sept. 14, 72 had received transplants, 13 were alive on the waiting list and 25 had died.

``It is possible that this serious adverse events rate may drop as clinicians gain more experience with the device's implantation,'' the FDA staff said.

About 5 million Americans suffer from severe heart failure, a condition that kills more than 50,000 people a year. Clearance would help Thoratec gain share in the $3 billion U.S. market for devices that pump blood for patients awaiting transplants.

New Generation

Thoratec's device is part of a new generation of smaller mechanical pumps that spin tiny blades to improve blood circulation. Ventracor Ltd. of Australia and MicroMed Cardiovascular Inc. in Houston make similar products.

There were no significant differences between the adverse events patients experienced with HeartMate II compared with an older model, the FDA panel said. The rates of bleeding and infection were similar to those of previous devices, according to the documents.

About 2,500 patients receive heart transplants in the U.S. each year, less than 1 percent of the total number of people who need the organ replaced. Congestive heart failure, the most severe form, occurs when reduced blood flow causes fluid buildup in surrounding tissue and potentially fatal swelling.

Sometimes the liquid pools in the lungs and interferes with breathing, causing shortness of breath and making physical activity difficult. Heart failure can also impair the kidneys' ability to flush waste fluids from the body. It can be caused by birth defects, heart attack, infection or high blood pressure.

HeartMate II helped 80 percent of women survive for six months in a study published earlier this month, compared with 81 percent of men. The 195-patient trial included people whose devices were removed after transplant as well as some who remained on the device. (ENDS)

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