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FDA clears Trevo Pro Retrieval System to treat acute ischaemic stroke


Tuesday, 14 Aug 2012 10:04
Trevo Pro Retriever
Trevo Pro Retriever

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Stryker for its Trevo Pro Retriever, a clot removal technology designed to treat patients experiencing acute ischaemic stroke.  


The Trevo Pro Retriever demonstrated strong clinical results in the TREVO 2 clinical trial presented at the 2012 European Stroke Conference in May, in Lisbon. This technology demonstrated the highest rate of revascularisation in a randomised embolectomy stroke device trial, and achieved significantly better post-procedure revascularisation than the Merci Retriever (Concentric Medical/Stryker)―92% in the Trevo Retriever arm compared to 76.7% in the Merci Retriever arm.

Other measures of performance also strongly favored the TrevoPro Retriever, including improvement in the National Institutes of Health Stroke Scale (NIHSS) score, excellent composite safety endpoints and shorter hospital stays.


“The launch of this device is another great stride in the evolution of stroke care,” said Gary Duckwiler, TREVO 2 investigator, 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 TrevoPro 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,” said neurologist Wade Smith, 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 centre quickly for treatment.”




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