Increased risk of stroke or death when using the Stryker Wingspan Stent System outside of approved indications

A Safety Communication issued by the Food and Drug Administration says studies show that when Stryker’s Wingspan Stent System (Wingspan) was used in patients outside of the FDA-approved indications for us, a higher incidence of stroke or death occurred within 72 hours of the procedure. 

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, also called intracranial atherosclerotic disease (ICAD), which puts patients at serious risk of life-threatening strokes due to reduced blood flow to the brain. Unfortunately, few treatment options are available for these patients.

Wingspan was approved through the Humanitarian Device Exemption (HDE) regulatory pathway, which required that it could be used to treat or diagnose diseases/conditions that affect not more than 8,000 people between 22 and 80 years old in the U.S. annually. Also, the treating physician must have received Institutional Review Board (IRB) approval to use the Wingspan at the clinical site. In addition, patients must meet all of the following criteria:

· have had two or more strokes despite aggressive medical management

· most recent stroke occurred more than seven days prior to planned treatment with Wingspan

· have 70-99 percent stenosis due to atherosclerosis of the intracranial artery related to the recurrent strokes

· 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.

In 2012, FDA said it ordered Stryker to conduct a postmarket surveillance study (Section 522 study). Stryker initiated the WEAVE study to fulfill the requirement. The FDA also publicly informed healthcare providers and patients about revised labeling based on the review of available safety information.

A total of 198 patients were treated using Wingspan in the study. Of the 198 patients treated, 152 patients met the FDA-approved indications for use criteria, and 46 patients did not meet the approved indications for use criteria. 

Nine strokes occurred in the territory of the stented artery. Seven strokes were ischemic and two strokes were hemorrhagic. Out of nine patients who had a stroke, eight had modified Rankin Scale scores available at Day 90 follow up. Of these eight patients, 50 percent (4/8) recovered by day 90.

Treatment outside of the FDA-approved indications included: less than seven days since the last stroke (n=4), less than two qualifying strokes (n=3), modified Rankin Scale score of 4 or 5 (n=3), not refractory to medications (n=1), treatment was unrelated to intracranial atherosclerosis disease (ICAD) (n=1). Patients may have had more than one condition outside of the FDA-approved indications.

Based on the WEAVE study results and other available safety information, FDA says 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. 

FDA recommends healthcare providers use Wingspan only in patients who are between 22 and 80 years old AND who 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 previous stroke and have a modified Rankin Scale score of three or less prior to Wingspan treatment.

· Be aware that the use of Wingspan in patients who do not meet the FDA-approved indications for use criteria significantly increases the risk of stroke or death.

· Consider patient selection carefully after reviewing the approved labeling, including the indications for use, contraindications, warnings, and precautions.

· When using Wingspan, treat only the vessel that caused the stroke.

· Be aware that Wingspan is only approved by the FDA as an HDE device for a very specific group of patients.

· 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.

· Only use Wingspan if you have been trained to perform neurointerventional procedures as well as properly trained and proctored by the manufacturer to use the device.