Public Citizen Calls for FDA Action On ‘Misleading’ Wingspan Stent Site

The prominent consumer watchdog group Public Citizen is calling on the FDA to take action against the makers of the Stryker Wingspan brain stent, indicating that the manufacturers’ website promoting the device is misleading.  

In a letter to FDA officials (PDF) dated April 3, Public Citizen called on the agency to take enforcement action against Stryker Neurovascular and Boston Scientific “for publishing false and misleading information on their website” regarding the Wingspan Stent System. In the past, the group has called for the devices to be completely removed from the market.

According to the letter, the website includes a disclaimer that inaccurately claims that the Wingspan is authorized by federal law for use in cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with ≤ 50% stenosis that are accessible to the system. However, Public Citizen says that statement does not include important limitations that were added to Wingspan uses in August 2012, and said the statement should say that the indication is for patients with ≥ 50% stenosis.

Public Citizen also accuses the Stryker website of listing a number of reports on Wingspan research without including the only large, prospective, randomized clinical trial, which found that use of the Wingspan more than doubled the risk of stroke or death.

The group says Boston Scientific, which manufactures the stent for Stryker, also has similar misleading information on its website as well.

The FDA is being urged to take immediate action against the companies, to ensure that they are putting out complete and accurate information regarding the stents.

Stryker Wingspan Stent Problems

The Stryker Wingspan is a narrow mesh tube implanted in narrowed arteries to the brain to prevent strokes among people who have already suffered one. The stent was approved as a humanitarian use device (HDE), which allowed Boston Scientific, the original designer, to get it approved with only one uncontrolled trial involving 45 patients, Public Citizen stated.

In April 2011, the U.S. National Institute of Neurological Disorders and Stroke (NINDS) ordered a halt to further clinical trials of the Wingspan stent, after almost 15% of the patients implanted with the device suffered strokes or died in the first month. The trial included 451 patients, half of whom were treated with the Wingspan and a drug regimen of Plavix and aspirin, and the other half treated with just drugs alone. Only 6% of those given just the drugs suffered strokes or death.

An independent monitoring board stopped the trials, saying it was unethical to continue.

In December 2011, Public Citizen petitioned the FDA to issue a Stryker Wingspan stent recall, indicating that the risks associated with the product outweigh any potential benefit for patients. The agency has failed to act on the petition.

On August 8, 2012, the FDA instead issued a drug safety communication narrowing the approved uses for the Wingspan brain stent, restricting use to patients who suffer recurrent stroke, despite continued medical management, and who meet a number of other criteria. The FDA indicated that Wingspan recipients must be between the ages of 20 and 80 years old, have had two or more strokes, and the last stroke must have been at least a week before treatment. Patients must also have a 70-99% narrowing of the intracranial artery related to recurrent strokes and have made good recovery from previous stroke.

The FDA also determined that the Wingspan should not be used for the treatment of stroke with an onset of symptoms within seven days or less of treatment or for the treatment of transient ischemic attacks.

Public Citizen says that the websites for those products do not mention those new restrictions.

“By posting only favorable studies and failing to include a complete and accurate disclaimer on its website regarding uses of the Wingspan Stent System, Stryker’s webpage labeling for the device seems to fit the statutory definition of misbranding,” Dr. Michael Carome, director of Public Citizen’s Health Research Group, said in a press release.”The FDA needs to step in and enforce the law.”