FDA Limits Use of Stryker Wingspan Brain Stent
August 9th, 2012 // 2:16 pm @ jmpickett
The U.S. Food and Drug Administration said Wednesday it has limited the use of a Stryker Corp. (SYK) brain stent used to open narrowed arteries in some patients who have had repeated strokes.
The company’s Wingspan Stent System was approved in 2005 to treat patients who have 50% or greater narrowing in arteries in the brain and had not improved with drug treatment. The narrowing of such arteries is caused by the buildup of plaque, which in turn can cause strokes from the reduced blood flow to the brain.
The product is designed to reopen narrowed arteries to potentially prevent additional strokes.
However, the FDA said clinical data have shown that the stent may increase the risk of strokes and heart attacks in some patients.
The agency narrowed the use of the Wingspan stent system to patients ages 22 to 80 years old who have a narrowing of the arteries of 70% to 99%, have had at least two previous strokes and were considered to have made a good recovery from those strokes. Patients’ most recent stroke also should have occurred more than seven days prior to planned treatment with Wingspan, the FDA said. Stryker didn’t immediately return a request for comment, but the company has previously said it would cooperate with the agency.
In March the matter was brought to an FDA advisory panel for discussion. While the panel said clinical data were lacking showing patients benefited from the device, some panel members said it might be appropriate for a small segment of patients.
The advocacy group Public Citizen petitioned the FDA last December seeking removal of the Wingspan device from the market. The FDA rejected that petition Wednesday.
“Even for those patients getting the device according to the new labeling, it is not clear that the benefits outweigh the risks,” said Dr. Sidney Wolfe, Director, Public Citizen’s Health Research Group.
A study published in the New England Journal of Medicine in September found that the risk of stroke recurrence or death with the Wingspan device was 14.7% among patients getting the stent plus drug treatment, versus 5.8% in the drug-only group. Most of the adverse events with Wingspan took place within a day of having it put in and all of the events took place within six days.
When patients were followed for an average of one year in the study, researchers found that 20% of stent patients and 12.2% of patients getting only drugs had died or suffered another stroke. There were 451 patients in the study, which was halted early after the heightened risk of the device was discovered.
The FDA said there were differences in patients enrolled in that study and those enrolled in the study that supported the 2005 approval. The agency said it thinks the Wingspan stent system should remain a treatment option for a “specific subgroup of patients who have exhausted other options.”
