The FDA should immediately withdraw its approval of the Wingspan stent systems used to prevent strokes in those patients who already have had one, or so says consumer advocacy group Public Citizen in a petition. The group is joined by former FDA official Dr. Larry Kessler in pushing for the move, maintaining that results from a recent study finds the device actually increases the risk of subsequent strokes and death.
The group also pushes the agency to order the device's manufacturer, Stryker Medical ($SYK), to recall all unused Wingspan systems because, when combined with aggressive medical treatment, they provide no additional benefits. Instead, they cause more harm than other aggressive medical treatments alone, the group's petition states.
Findings from the NIH-funded SAMMPRIS study published in The New England Journal of Medicine in September concluded patients at a high risk for a second stroke who received intensive medical treatment had fewer strokes and deaths than those who received the Wingspan system in addition to the medical treatment. The data also showed a more than 2.5-fold increase in strokes or death caused by the Wingspan system, Public Citizen says.
As the NIH noted in its release on the study, new enrollment was stopped in April because early data showed significantly more strokes and deaths occurred among the stented patients at the 30-day mark compared to the group who received the medical management alone.
Wingspan and the Gateway PTA balloon catheter was developed for the treatment of intracranial atherosclerotic disease to deliver new options for ischemic stroke. It was approved in 2005 as a humanitarian use device (HUD) and is used to place a stent in narrowed arteries that supply blood to the brain of those patients who are at risk of another stroke. The developer, Boston Scientific ($BSX), only had to provide evidence that the system was effective prior to its approval, according to Public Citizen.
Kalamazoo, MI-based Styker obtained Wingspan through its acquisition of the neurovascular division of Boston Sci last year.
"These compelling post-market data about the Wingspan stent provide an opportunity for the FDA to show to industry, the clinical community and most of all to patients that the agency is serious about exercising its authority by withdrawing the HDE immediately and insisting on a recall to ensure the devices on the U.S. market are both safe and effective," former CDRH Director Kessler says in the statement.
In an emailed statement to FMD, Stryker said it continues to support the Wingspan and the Gateway PTA balloon catheter as an approved HUD for improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease who have failed medical therapy.
"The SAMMPRIS Trial did not follow the current HDE (Humanitarian Device Exemption) indication for use; it focused on studying the treatment of severe intracranial atherosclerotic disease, early in the treatment lifecycle and with an aggressive drug treatment regimen and rigorous oversight of medication compliance."
Furthermore, "[t]he Wingspan Stent System with Gateway PTA Balloon Catheter is for patients who are refractory to medical therapy. In the SAMMPRIS trial, it was not required for patients to be refractory to medical therapy to be enrolled."
- see the Public Citizen release