FDA could revoke Stryker Wingspan brain stent approval

Stryker's ($SYK) Wingspan intracranial stent faces an uncertain future in the U.S. market.

Sold since 2005 under a humanitarian device exemption, the stent now appears to be too risky to use except in the most difficult-to-treat cases, the FDA's neurological devices advisory committee concluded. While it didn't formally vote to decide if the stent's benefits outweighed its risks, the 16-member panel largely agreed with an FDA report also determining the stent wasn't any more effective than blood thinners and other standard therapies to help prevent stroke, according to coverage from Reuters, The Wall Street Journal, MedPage Today and others.

In a particularly ominous move for the product's future, most panel members signed off on a recommendation that FDA officials re-evaluate whether Wingspan should be sold in the U.S. at all. That's significant, because the FDA doesn't have to follow recommendations from its expert committees, but its decisions do often echo panel votes. Other than an outright market removal, one possible outcome here is a revised, more limited approval scope for Wingspan. Another option is that Stryker may have to supply additional data to support the stent's continued use, according to the WSJ.

All of the harsh reaction to Wingspan's safety follows an NIH report in September that the stent was more likely than standard drug treatments to cause strokes in patients.

As the WSJ explains, fewer than 2,000 patients a year are given the stent implant, which is designed to treat patients with multiple strokes due to intracranial artery blockage. By gaining the humanitarian exemption, the device reached the marketplace without a full randomized, controlled clinical study, according to the WSJ story, in part because regulators initially concluded that drug therapy wouldn't work for this class of patients. The article notes that drug therapy has since gotten better.

Stryker told the WSJ in response to the panel recommendation that it would work with regulators moving forward and that Wingspan "is the only product approved for this indication on the U.S. market."

- here's the WSJ story (subs. req)
- read the Reuters coverage
- consider MedPage Today's take