A few months ago, following the 2012 American Association of Neurological Surgeons (AANS)? conference, we wrote about the controversy surrounding Stryker's Wingspan Stent. Specifically, following some negative trial results, the consumer watchdog group Public Citizen was pressuring the FDA to withdraw humanitarian device exemption (HDE) approval for the stent.
Recently, the FDA released its decision on the topic, and it's overall good news for Stryker: The FDA rejected Public Citizen's petition to remove the stent from the market. It did, however, limit the use for the stent to patients with narrowing of the arteries of 70 to 99%, who have had at least two previous strokes, and who were considered to have made good recoveries from the strokes. Previously, the stent could be used in patients with 50% or greater narrowing of the arteries who had not improved with drug treatment.
Realistically though, this limitation won?t make much of a difference to the use of the Wingspan stent. It pretty much only is currently used for extreme cases where the patient has few other options. HDE approval limits the use of the product to 4,000 cases a year anyway, so it's not like this product was widely used.
Neurovascular stents are projected to generate about $50 million in revenue in the US by 2016, and Stryker remains the only company present in this space as of mid-2012. Although Codman & Shurtleff is poised to enter the market in the next few years, this decision is undoubtedly a good one for Stryker. Industry experts also indicated that European physicians were following the decision as well, and many would have stopped using the device if the FDA had pulled approval.
So overall, there's no doubt that there's room for improvement in this market, but for now, neurovascular stenting remains a last-ditch option for patients at risk of strokes.