The FDA has cleared two of Stryker’s clot retrieval devices as a first-line therapy for ischemic strokes to be given alongside a clot-dissolving drug. The devices were first cleared in 2012 to remove blood clots in stroke patients who could not receive the drug or for whom the drug did not work.
“This is the first time FDA has allowed the use of these devices alongside [the clot-dissolving drug] t-PA, which has the potential to help further reduce the devastating disabilities associated with strokes compared to the use of t-PA alone,” said Carlos Peña, director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health, in a statement. The hope is to reduce speech difficulties, paralysis and other disabilities that result from stroke.
The Trevo ProVue retriever is delivered to the site of the blood clot via catheter in a procedure guided by fluoroscopic imaging. Once it reaches the clot, the device is passed through it, allowing it to grip the clot and be pulled back through the blood vessel for removal, according to the statement.
T-PA must be given within three hours of stroke onset, and the Trevo clot retrieval devices should be used within 6 hours of symptom onset and only after the drug has been administered, the FDA said in the statement. Until now, the only initial treatment for acute ischemic stroke was intravenous t-PA. The new marketing approval will bring the Trevo devices to a broader patient population.
The clearance comes after a clinical trial in which 96 patients were treated with t-PA and Trevo and 249 patients received only t-PA and medical management. Of the Trevo patients. 29% were “functionally independent” three months post-stroke compared to 19% of those who only received medication, according to the FDA.
Stryker picked up the Trevo devices in its $135 million acquisition of Mountain View, CA-based Concentric Medical in 2011. The purchase was Stryker’s entry into the interventional neurovascular arena, allowing it to dive into the fast-growing acute ischemic stroke business. According to the CDC, stroke is the fifth leading cause of death in the U.S. and kills nearly 130,000 Americans annually. Ischemic strokes make up 87% of all strokes.