Group wants FDA to recall brain stent

A petition has been filed with the U.S. Food and Drug Administration to recall a brain implant designed to prop open obstructed arteries in people vulnerable to stroke.

The petition was submitted late last month by Public Citizen's Health Research Group, a Washington, D.C.-based medical watchdog organization that has long challenged the safety of numerous FDA-approved medical devices and medications.

FDA spokeswoman Michelle Bolek said the agency is reviewing documents requesting the recall. She could not say when a decision would be rendered.

The device, called the Wingspan stenting system, is designed to widen plaque-narrowed brain arteries. The tiny mesh tube acts as a scaffold that opens an artery to allow the free flow of blood.

Although the concept is similar to other types of stents, the Wingspan was designed to be used in very delicate, hard-to-reach areas of the brain. It is significantly smaller than the longer-used and substantially better studied stents inserted in the carotid arteries (on either side of the neck) to prevent strokes, or devices implanted in coronary arteries to stave off heart attacks.

A letter from Larry Kessler, former director of the FDA's Center for Devices and Radiological Health, accompanies the Health Research Group's petition.

"I can see no reason why this device should continue to be available," wrote Kessler, now a public health professor at the University of Washington in Seattle.

In September, a clinical trial of 780 people that compared the device to the use of medications found that blood thinners and drugs to control blood pressure, cholesterol and diabetes prevented strokes better than the stent.

Nearly 15 percent of the patients who received a stent suffered a stroke or died within 30 days. "Clearly, the risks outweigh the benefits," said Dr. Sidney Wolfe, director of Public Citizen's health group.

When the stent was placed in a fragile brain artery to prevent a stroke caused by plaque, a number of patients in the study suffered another kind of stroke caused by the vessel's rupture.

"This is an inherently dangerous device," added Wolfe.

Officials in the California neurovascular division of Stryker, which owns the Wingspan, didn't respond to Newsday's inquiries this week.

Dr. Jonathan Brisman, director of cerebrovascular and endovascular neurosurgery at Winthrop-University Hospital in Mineola, said he has implanted the Wingspan in Long Island patients, but reserves it for those with no other options.

Brisman said there should be better supervision and credentialing of doctors who implant the device because the "complication profile, even in experienced hands, can be quite high."

"I don't think it should be recalled," Brisman added. "It is currently the only FDA-approved stent for intracranial atherosclerotic disease and I would want the stent to continue to be available for the small group of patients that truly need it."

Wolfe said the unexpected number of complications in the study forced the federal government last year to halt the $20 million project.

An arm of the research was conducted at Stony Brook University Medical Center. All Stony Brook patients fared well, doctors reported last year. Stony Brook did not comment on the petition.

The device was FDA-approved in 2005 on a humanitarian exemption, based on a much smaller study of 45 older, extremely high-risk patients who had already suffered a stroke and failed medical management.

Last year's study involved many younger patients; some had never experienced a stroke, Bolek noted.

She said the FDA has approved the device only for people like those in the original study. The stent costs about $21,000 per patient.