April 25, 2019
“For every FDA medical device approval, we carefully assess the benefits and risks of the device to ensure patients have access to devices that will positively impact their health. This benefit risk paradigm can shift when a device intended for a specific patient population is used in other ways. In the case of the Wingspan Stent System, the device is approved only for use in a specific subset of patients with a life-threatening neurological condition. While the device can play an important role in opening narrowed arteries in the brain of certain patients diagnosed with intracranial stenosis who are experiencing repeated strokes, new study data issued today reinforces that the risk of stroke or death is higher when this device is used in patient populations outside of the FDA-approved indications for use,” said William Maisel, M.D., M.P.H., chief medical officer in the FDA’s Center for Devices and Radiological Health. “As a follow up to previous alerts about this device, today the FDA is reminding health care professionals and patients to carefully follow the Wingspan device labeling, instructions for use and to consider the specific patient selection criteria for this device so they can appropriately determine whether the device is right for them. This alert is part of our ongoing commitment to device safety and our work to protect patients when we become aware of safety concerns involving medical devices.”
The Stryker Wingspan Stent System (Wingspan) is used to open narrowed arteries in the brain of patients who are experiencing repeated strokes due to a serious condition, called intracranial stenosis, in which a buildup of plaque causes the arteries to narrow. Patients with intracranial stenosis are at serious risk of life-threatening strokes due to reduced blood flow to the brain from narrowed or blocked arteries, and there are few treatment options available for managing this condition. Wingspan, which was approved through the Humanitarian Device Exemption (HDE) regulatory pathway, is approved only for a specific group of patients with this condition as outlined in the indications for use in the device labeling instructions for use.
Today, the FDA communicated about the results from the Wingspan StEnt System PostmArket SurVEillance (WEAVE) study. The study was conducted in follow up to actions the FDA took in 2012 to address safety concerns with the device. In 2012, the FDA worked with Stryker to update their labeling for the Wingspan device, which included revised indications for use based on a review of safety information that showed that Wingspan may present unacceptable risks, such as stroke and death. In addition, the FDA ordered Stryker to conduct a postmarket surveillance study and Stryker initiated the WEAVE study to fulfill this requirement.
The WEAVE study data shows a higher incidence of stroke or death when Wingspan is used outside of the FDA-approved indications for use. A summary of the WEAVE study results and recommendations for health care professionals and patients are included in a Safety Communication issued today. The safety communication reminds health care professionals to consider patient selection carefully after reviewing the approved labeling including the indications for use, contraindications, warnings and precautions. Generally, a patient may be treated with Wingspan only if the treating physician has received Institutional Review Board (IRB) approval to use the Wingspan at the clinical site.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.