New labeling changes approved by the Food and Drug Administration limit the patients eligible for treatment with the Stryker Wingspan Stent System, according to a statement and safety communication issued by the agency on Aug. 8.
The changes specify the patients most likely to benefit from treatment with the stent system. Data from studies conducted since the system’s approval in 2005 suggest that the risks, including stroke and death, may outweigh the benefits for some patients, according to the press release.
"After careful consideration of available safety information, the FDA believes this device should remain available for this specific subgroup of patients who have exhausted other options," Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the statement.
Under the new label, the Wingspan system is approved only for patients aged 22-80 years who meet four specific criteria: two or more strokes despite aggressive medical management; a most recent stroke more than 7 days prior to planned treatment with the Wingspan system; 70%-99% stenosis (due to atherosclerosis of the intracranial artery related to the recurrent strokes); and good recovery from previous strokes, defined in part by a modified Rankin score of 3 or less before treatment with the Wingspan system.
According to the safety communication, the Wingspan system should not be used for "the treatment of stroke with an onset of symptoms within 7 days or less of treatment; or for the treatment of transient ischemic attacks (TIAs)."
The FDA approved the changes after reviewing data from the original clinical study, postapproval studies, and the SAMMPRIS (Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) study.
The safety communication states that "a patient may be treated with Wingspan only if its use has been approved in advance by the treating physician’s Institutional Review Board (IRB)," and that the physician is responsible for obtaining IRB approval before treating a patient with the Wingspan system.
Clinicians can report adverse events associated with the Wingspan system to the FDA via the MedWatch program. The safety communication can be viewed here.