
Med-tech titan Stryker (NYSE:SYK) lost no love on Wall Street following an FDA report finding that its Wingspan brain stent was no better, and sometimes worse, than aggressive drug therapy in preventing strokes in patients with narrowed blood vessels in the brain.
A report compiled for the FDA’s upcoming review associated the Wingspan stent with "no added benefit, and in some cases, significantly worse outcomes" than management with drugs and coaching.
This Friday the FDA’s neurological devices panel will consider pre-market and post-market data for Wingspan, including the Gateway PTA balloon catheter and stent delivery system, and determine whether more clinical data is necessary.
The panel’s early report reiterates concerns from a 2011 study linking the Wingspan stent to higher stroke and death rates when compared with patients who received only lifestyle coaching and blood-thinning medication.
The findings came from the multi-center Sammpris clinical trial funded by the National Institutes of Health, the 1st stroke prevention trial to compare intracranial stenting with medical therapy and lifestyle coaching that focused on quitting smoking, increasing exercise and managing diabetes and cholesterol.
Patients treated with drugs and medical management had a 5.8% stroke and death rate at 30 days, less than half the 14.7% rate for patients who received drugs, medical management and the Wingspan stent. After 1 year, the stroke and death rate rose to 12.2% for the non-stented group and 20% for the patients who received the device
"Stroke specialists are all disappointed that stenting did not have the beneficial impact we thought it would have," principal investigator Dr. Cathy Sila said at the time. "We have always known that it is much more difficult to stent a blockage in the brain than in the heart but we cannot abandon this technology. We need to better understand the tolerances of the brain vasculature and continue to reengineer our tools."
The study results drew the attention of consumer watchdog group Public Citizen, which called for the FDA to recall the Wingspan device. Former FDA medical device director Larry Kessler joined the petition, asking that the agency pull the stents off the market and revoke their clearance "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 petition.
Among growing concern resulting from the NIH study, the Kalamazoo, Mich.-based orthopedics giant defended the stent system, noting that the Sammpris trial didn’t consider the device as it’s intended to be used.
"The Sammpris trial did not follow the current HDE indication for use; it focused on studying the treatment of severe intracranial atherosclerotic disease, early in the treatment lifecycle and with an aggressive drug treatment regimen and rigorous oversight of medication compliance," Stryker spokeswoman Tamara Cutler told MassDevice in an email in December 2011.
Stryker is currently the only company with the FDA’s okay to sell a brain stent for certain high-risk patients in the U.S., having acquired it as part of a $1.5 billion cash buyout of Boston Scientific’s (NYSE:BSX) neurovascular business in October 2010.
Wingspan won FDA clearance through a humanitarian device exemption along with the Gateway balloon catheter for patients who didn’t respond to drug treatment in 2005, and thousands of patients have received the stent so far.
News of the unfavorable characterization didn’t cause much of a stir on The Street, where SYK shares were up 3¢ to $54.85 as of about 5 p.m. today. Wingspan isn’t a major source of sales for the device giant and use of the device is limited to 4,000 patients per year under its IDE status.