FDA Clears Stryker's Trevo Pro Retrieval System

August 13, 2012—Stryker Corporation (Kalamazoo, MI) announced that its Trevo Pro Retriever system has been granted 510(k) market clearance by the US Food and Drug Administration. The device uses the company's Stentriever technology for clot integration and retrieval in patients experiencing acute ischemic stroke.

According to Stryker, the randomized TREVO 2 clinical trial results demonstrated that treatment with the Trevo Pro Retriever resulted in a high rate of revascularization and achieved a significantly better postprocedure revascularization rate than the company's Merci Retriever (92% vs 76.7%). The Trevo Pro Retriever also demonstrated improvement in the National Institutes of Health Stroke Scale score, excellent composite safety endpoints, and shorter hospital stays. The Trevo and Merci devices were developed by Concentric Medical, Inc. (Mountain View, CA), which Stryker acquired in October 2011.

As reported in Endovascular Today, the TREVO 2 data were presented in May at the 2012 European Stroke Conference in Lisbon, Portugal.

“The launch of this device is another great stride in the evolution of stroke care,” commented TREVO 2 investigator Gary Duckwiler, MD, neuroradiologist at the University of California Los Angeles Medical Center. “Concentric Medical, which is now owned by Stryker, has a long history of partnering with physicians to develop devices specifically designed to remove blood clots from a blocked artery in the brain. The new Trevo Pro Retriever is easy to use and very effective at opening blood vessels, allowing physicians to have a significant impact on clinical outcomes.” 

“In this patient population, rapidly restoring blood flow to the brain is critical,” added Wade Smith, MD, neurologist at the University of California San Francisco Medical Center. “This technology advances our ability to help many patients avoid the devastating effects from a large stroke if they can get to a comprehensive stroke center quickly for treatment.”