US FDA to decide next step for Stryker brain stent

Therapies Thursday, March 22nd, 2012

Reuters: By Anna Yukhananov, Wed Mar 21, 2012 12:38pm EDT.
* Stent meant to unblock arteries in brain

* NIH-funded study showed it did more harm than drugs

* Watchdog group calls for withdrawal

* FDA advisers to discuss stent on Friday

WASHINGTON, March 21 (Reuters) – U.S. regulators on Wednesday questioned whether they should ask Stryker Corp to conduct further trials of a stent used to unblock arteries in the brain, after a government-funded study showed the device did more harm than good.

The stent, called the Wingspan system, has been on the market since 2005 and is used to open blocked arteries in the brain when clot-dissolving drugs do not work. It is supposed to improve blood flow and prevent people who have already had a stroke from having another one. Read More

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