A recently completed postmarket surveillance study showed a higher incidence of stroke or death when Stryker's Wingspan Stent System was used outside of the approved indications.
Off-label medical device use is a tricky subject and one that has been at the center of many heated debates. It is strictly against the law for manufacturers to promote their products for off-label use, however, physicians have the discretion to use a device in an off-label manner if such use might be beneficial to the patient.
Sometimes, however, FDA does try to intervene if the off-label use of a particular device raises a concern about patient safety. Case in point, Stryker's Wingspan Stent System.
Approved in 2005 under a Humanitarian Device Exemption, the Wingspan has provoked advocacy groups for years, yet the device has remained on the market. Back in 2012, the advocacy group Public Citizen petitioned FDA to withdraw approval for the stent system that is designed to prevent recurrent strokes in patients who have already had one stroke. The group pointed to a study that found the device actually increased the risk of subsequent strokes and death.
The petition was denied later that year. FDA did, however, narrow the indication for Wingspan use to a select group of patients and conditions, as outlined in the box below.
FDA also ordered Stryker in 2012 to conduct a postmarket surveillance study, and Stryker initiated the WEAVE study to fulfill that requirement. That study was recently completed and showed a higher incidence of stroke or death when the Wingspan was used outside of the approved indications.
|Outcome (within 72 hours)||Patients Who Met Approved Indications||Patients Who Did Not Meet Approved Indications|
|Death||2 (1.3%)||2 (4.3%)|
|Stroke Without Death||2 (1.3%)||9 (19.6%)|
|Total With Stroke or Death||4 (2.6%)||11 (23.9%)|
|Total Without Stroke or Death||148 (97.4%)||35 (76.1%)|
|Total Number of Patients Treated||152||46|
The study was designed as a prospective, single-arm study conducted at 24 U.S. clinical sites to assess the rates of stroke or death within 72 hours of placing the stent. Of the 198 patients enrolled in the study, 152 patients met the approved indications and 46 patients did not.
The table on the right shows the rates of stroke or death between these two groups. In the group who did not meet FDA approved indications, all nine strokes occurred in the territory of the stented artery, the agency noted. Seven strokes were ischemic and two strokes were hemorrhagic. Also, out of the nine patients in that group who had a stroke, eight had modified Rankin Scale scores available at 90-day follow up. Of these eight patients, four of them (50%) recovered by day 90.
Also, treatment outside of the approved indications included: four patients had experienced a stroke less than seven days prior to Wingspan treatment, three patients had not experienced two or more strokes, three patients had a modified Rankin Score above a three; one patient was not refractory to medications, and one patient's treatment with the Wingspan was not related to intracranial atherosclerosis disease. Patients in this group may have had more than one condition outside of the approved indications, FDA noted.
The agency said it will continue to work with Stryker to revise the Wingspan labeling to ensure healthcare providers are aware of the increased risks of stroke or death when used outside the FDA-approved indications for use.