FDA knocks Stryker's Wingspan stent

Stryker ($SYK) is facing a sobering FDA report that points to the company's Wingspan stent as being more damaging than helpful in some cases and of neutral benefit in others, according to a Bloomberg story. Regulators said that blood thinners and other standard therapies for stroke prevention could be better alternatives in certain situations than the stent itself, which gained approval in 2005 under a humanitarian device exemption. Their assessment follows an NIH study, published in September, concluding the Wingspan stent was more likely to cause strokes in patients than drug treatments, the story notes. An FDA panel of experts will meet March 23 to review Wingspan's safety and effectiveness. Story

Suggested Articles

The former Fierce 15 winner’s SuperMap program was cleared to guide electrophysiologists in the treatment of stable and transient arrhythmias.

Insulet announced new agreements with Abbott and Dexcom to connect their continuous glucose monitors with its upcoming tubeless, digital insulin pump,

In an SEC filing, Baxter International disclosed that it may have overstated its income over multiple years, inflating it by about $276 million.