Former CDRH director joins Public Citizen in demanding recall of Stryker's brain stent

December 22, 2011 by Arezu Sarvestani

Former CDRH director Larry Kessler joins consumer watchdog group Public Citizen in asking the FDA to recall Stryker's Wingspan brain stenting system and withdraw its humanitarian device exemption.

Updated Dec. 22, 2011, at 12:30 p.m. to include comments from Stryker.

Brain stenting

Consumer watchdog group Public Citizen asked the federal government to recall Stryker Corp.'s (NYSE:SYK) Wingspan brain stent over concerns that it may lead to heightened risk of stroke and death.

Former FDA medical device director Larry Kessler joined the petition, asking that the agency pull the stents off the market and revoke their 510(k) 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.

The Wingspan system, cleared under the FDA's humanitarian device exemption pathway in 2005, places a stent in narrowed arteries supplying blood to the brain.

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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 Corp.'s (NYSE:BSX) neurovascular business in October of last year.

Among growing concern resulting from the National Institutes of Health SAMMPRIS study, the Kalamazoo, Mich.-based orthopedics giant defended the stent system, noting that the NIH study didn't consider the device as it's intended to be used.