FDA clears Stryker's next-gen stroke treatment device

Stryker ($SYK) won FDA clearance for the Trevo Pro Retriever next-generation stroke treatment device, the Michigan device company disclosed. The news comes almost a year after Stryker snatched up Trevo's developer, Concentric Medical, for $135 million in cash.

Trevo's 510(k) clearance launches a device designed to rapidly remove blood clots from a brain's blocked artery, a key element when trying to minimize or prevent brain damage in patients with acute ischemic strokes.

In May, Stryker revealed robust results from the product's Trevo 2 randomized embolectomy stroke device trial at the 2012 European Stroke Conference. The Trevo Retriever produced a 92% rate of restoring blood flow, versus 76.7% for the Merci Retriever (also acquired as part of the Concentric deal). Patients with the Trevo device also produced improved National Institutes of Health Stroke Scores and were able to leave the hospital sooner. Researchers enrolled 178 patients in the trial at 27 U.S. and European health care facilities, and the trial initially began in February 2011. Results for Trevo 2 were also consistent with an earlier Trevo trial, the company said.

This is the second big FDA news for Stryker in less than a week. Separately, regulators addressed safety concerns over Stryker's Wingspan intracranial stent by dramatically narrowing its list of approved indications. The decision was a win of sorts for Stryker because the agency could have pulled the product from the U.S. market altogether. Approved under a humanitarian use device exemption since 2005, the FDA determined, in part, that Wingspan should still be used for patients with treatment-resistant (refractory atherosclerotic disease with a 50% or higher narrowing of the intracranial arteries and also for patients who have had two or more strokes even with aggressive medical treatment.

- read Stryker's 510(k) announcement
- recap the Stryker/Concentric acquisition story