FDA Restricts Use of Stryker Brain Stent

The Food and Drug Administration has issued updated safety labeling information for the Stryker Wingspan Stent System that will limit its use to a more specific group of patients.

The new guidelines would limit the amount of patients who should receive the Wingspan stent system. The brain artery stent should not be used in “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),” according to the FDA’s updated guidelines. The agency made these updates to the safety information on the Wingspan stent after reviewing the initial clinical data presented on the device and from a more recent trial, the Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study.

The Stryker Wingspan brain stent was approved in 2005 as a Humanitarian Use Device by the FDA. That requires a surgeon to gain approval from his or her’s Institutional Review Board before using it on a patient. The artery stent is used to prevent additional strokes in a patient who’s already suffered one or multiple events, suffering from intracranial stenosis.

A device approved through these means is only intended to treat about 4,000 people per year, meaning widespread use of the device has never been recommended but if a surgeon were to opt to use it, it would require a consensus between the patient, the surgeon, and the facility where it was implanted. The Wingspan stent is meant for “patients with treatment-resistant (refractory) intracranial atherosclerotic disease who have 50 percent or greater narrowing in the intracranial arteries,” according to the FDA’s initial approval guidelines.

The FDA is advising neurologists to “carefully review the new device labeling” on the Wingspan stent before suggesting it to prospective recipients. They should become familiar with its design and with the results of the SAMMPRIS clinical trial data to determine if a patient is a good candidate to receive the device. Surgeons and neurologists are also urged to report any adverse events involving this device to the FDA’s Adverse Event Reporting System so that it could better track the performance of the Wingspan stent.

The updated safety guidelines on this device were deemed necessary after numerous reports of complications involving patients who had received it. The limitations placed on potential good candidates for the Wingspan suggest it was being used on too wide a variety of patients and that was leading to an unexpected number of adverse events. Patients who may not have been the ideal candidates could have faired better at preventing additional strokes with different drug therapies before having the Wingspan stent implanted. Those who’ve received the Wingspan stent face a greater risk of death and of suffering additional strokes than patients who tried another drug therapy.

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