Stryker Wingspan Brain Stents Restricted Instead of Being Recalled

Federal health officials have decided not to recall the Stryker Wingspan brain stent, instead determining that it should be restricted to a smaller pool of potential patients due to safety concerns.  

According to a safety communication issued by the FDA on August 8, the approved indications for the Stryker Wingspan Brain Stent System are being narrowed in response to new studies and information from a clinical trial called the Stenting vs. Aggressive Medical management for Preventing Stroke in Intracranial Stenosis (SAMMPRIS) study.

The Stryker Wingspan is used to open narrowed arteries in the brains of patients diagnosed with intracranial stenosis, which involves a narrowing of the intracranial arteries caused by the build up of plaque. The Wingspan is a small mesh tube implanted in the narrowed arteries to the brain to open the arteries and prevent strokes in people who have experienced repeated strokes.

Concerns About Safety of Stryker Wingspan Brain Stent

The FDA approved the Wingspan brain stent as a Humanitarian Use Device (HDE) in 2005, for patients who have a 50 percent or greater narrowing of the arteries. HDE devices are designed to treat or diagnose a disease or condition that affects fewer than 4,000 people in the United States per year. This designation allowed the original designer of the device, Boston Scientific, to obtain approval with only one uncontrolled trial involving 45 patients.

In April 2011, the U.S. National Institute of Neurological Disorders and Stroke (NINDS) ordered a halt to further clinical trials of the Wingspan after determining that it was unethical to continue since almost 15% of the patients implanted with the Wingspan 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.

The FDA has determined that the safety concerns require a narrowing of the approved indications for use of the Wingspan stent, restricting use to patients who suffer recurrent stroke, despite continued medical management, and who meet a number of other criteria. Patients must be between the ages of 20-80 years old, have had two or more strokes, and the last stroke must be at least a week before treatment. Patients also must have a 70-99 percent narrowing of the intracranial artery related to recurrent strokes and have made good recovery from previous stroke.

The FDA determined 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 (TIAs).

Calls for Stryker Wingspan Stent Recall Rejected

In December 2011, the consumer watchdog group Public Citizen filed an FDA petition calling for a Stryker Wingspan stent recall to be issued due to the risks associated with use.

A month later, after the FDA failed to act on the petition, the group indicated that the failure to recall the Wingspan stent was “reckless”, suggesting that continued use was exposing patients to an unacceptable risk of serious harm, including death.

In response to the FDA’s decision to allow the Stryker Wingspan stent to remain on the market, Public Citizen indicated that the regulatory agency was ignoring evidence that links the system to an increased risk of stroke and death.