The FDA issued a Safety Communcation on April 25, 2019 entitled, “Use of the Stryker Wingspan Stent System Outside of Approved Indications Leads to an Increased Risk of Stroke or Death: FDA Safety Communication” in which the FDA warned: “a very specific group of patients, consistent with the current FDA-approved indications and patient selection criteria … , 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.”
Stryker’s Wingspan Stent System (Wingspan) is used to open narrowed arteries in the brain of patients diagnosed with intracranial stenosis who are experiencing repeated strokes. Intracranial arterial stenosis, or narrowing of arteries, is a serious condition caused by a buildup of plaque within the intracranial arteries. This may be referred to as intracranial atherosclerotic disease (ICAD). 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 is FDA-approved only for patients who are between 22 and 80 years old AND meet ALL the following criteria:
– who have had two or more strokes despite aggressive medical management;
– whose most recent stroke occurred more than seven days prior to planned treatment with Wingspan;
– who have 70-99 percent stenosis due to atherosclerosis of the intracranial artery related to the recurrent strokes; and
– who have made good recovery from the previous stroke and have a modified Rankin Scale score of three or less prior to Wingspan treatment. (The Rankin scale is used to measure the degree of disability at the time of evaluation. Lower scores indicate less or no disability.)
The FDA reported that the mandated postmarket surveillance study (Section 522 study) entitled “Wingspan StEnt System PostmArket SurVEillance (WEAVE)” found that a significantly higher incidence of stroke or death occurred within 72 hours of the procedure when the Wingspan was used in patients outside of the FDA-approved indications for use.
Of the 198 patients in the study who were treated using the Winfgspan, 152 patients met the FDA-approved indications for use criteria, and 46 patients did not meet the approved indications for use criteria. The study found that there was a higher incidence of stroke or death within 72 hours of the procedure when the Wingspan was used in patients outside of the FDA-approved indications for use.
The FDA concluded: “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.”
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