Medical devices maker Stryker (NYSE:SYK) isn’t downtrodden in light of the FDA’s decision to restrict use of the Wingspan brain stent system to a narrower group of patients – Stryker seems genuinely delighted.
The FDA yesterday announced its decision to limit use of the Wingspan system, which was approved in 2005 under a Humanitarian Device Exemption, to a more specific group of stroke patients who aren’t well-managed with drugs alone.
"Stryker is pleased to announce that we received communication from FDA concluding their review of the Wingspan Stent System and Gateway PTA Balloon Catheter and having determined that the Wingspan Stent should remain available for those patients who have failed to respond to, or who are ineligible for, an aggressive and comprehensive program of medical management," spokeswoman Tamara Cutler told MassDevice.com in an emailed statement. "
The FDA’s decision was a mixed blessing, since the restriction means the device will remain on the market, albeit with more limited patient access.
Consumer watchdog group Public Citizen had asked the federal government to recall Wingspan entirely over concerns that it may lead to heightened risk of stroke and death.
Former FDA medical device director Larry Kessler joined that petition, asking that the agency pull the stents off the market "because, when combined with aggressive medical treatment, they provide no additional benefit but cause significantly more harm than safer aggressive medical treatment alone," according to the group.
The federal watchdog agency opted against the recall, instead issuing new guidelines approving use of the device in patients aged 22-80 who have experienced at least 2 strokes despite "aggressive medical management." The devices should not be implanted in patients who have experienced a stroke within 1 week of surgery or for treatment of transient ischemic attacks, according to the new labeling.
"Stryker is pleased with the agency’s decision as it allows patients with intracranial atherosclerotic disease who have exhausted all available treatment options under the care of a qualified health care provider continued access to this life saving humanitarian device," according to the company. "Stryker is fully committed to partnering with our physician community to help them better understand the narrowed indications for product use reflected in the new product labeling."
The new labeling came in response to study results, published last year, which suggested that stroke and death rates in patients who received the Wingspan system in addition to drug treatment were 20% at 1 year, compared to 12.2% for patients on drugs alone.