The FDA yesterday posted a safety communication warning that the off-label use of Stryker‘s (NYSE:SYK) Wingspan stent system, designed to open narrowed arteries in the brain for patients with intracranial stenosis who experience repeated strokes, can increase the incidence of stroke or death.
The federal watchdog said that it received results from a mandated postmarket surveillance study from Kalamazoo, Mich.-based Stryker that showed that there is “a significantly higher incidence of stroke or death” within 72 hours for patients who underwent a procedure with the Wingspan stent outside its specific indications.
The Wingspan stent, approved through the Humanitarian Device Exemption pathway, is indicated for patients between 22 and 80 years old who have had two or more strokes despite aggressive medical management, whose most recent stroke occurred more than seven days prior to treatment, who have 70-99% stenosis due to atherosclerosis of the intracranial artery related to recurrent strokes and who’ve made a good recover and have a modified Rankin Scale score of three or less, the FDA said.
The Agency said that it worked with Stryker in 2012 to update the labeling for the wingspan device based on information from a neurological devices panel meeting held earlier that year. The FDA also ordered a postmarked surveillance study of the device, dubbed the WEAVE study.
Stryker’s WEAVE study was recently completed, with data from the study showing a higher incidence of stroke or death when the Wingspan stent was used outside its indications.
Data in the study came from 198 patients at 24 clinical sites in the U.S.. Of the 198 patients enrolled, 152 met the FDA-approved indications for use.
Results from the study indicate that patients who met the FDA-approved indications had a 1.3% risk of death, 1.3% risk of stroke without death, a 2.6% combined rate of stroke or death and a 97.4% rate of freedom from stroke or death.
Patients who did not meet the FDA-approved indications had a 4.3% rate of death, a 19.6% rate of stroke without death and a combined 23.9% rate of stroke or death, with only a 76.1% freedom from stroke or death, the Agency reported.
“Based on the WEAVE study results and other available safety information, a very specific group of patients, consistent with the current FDA-approved indications and patient selection criteria listed above, may benefit from the use of Wingspan. The FDA’s assessment of benefits and risks for this device considered that these patients are at serious risk of life-threatening stroke and have limited alternative treatment options,” the FDA wrote in its safety notice.
The federal watchdog went on to suggest that the Wingspan device be only used in patients who strictly meet the device’s indications.
The Agency said that it will continue to work with Stryker to revise labeling for the Wingspan and will provide any new information if it becomes available.
Earkier this week, Stryker shares stayed steady after the medical device maker posted first quarter 2019 earnings that topped expectations on Wall Street.