FDA approve Trevo Pro Retriever (Stryker) for clot removal - 15-Aug-2012

The Trevo Pro Retriever, from Stryker, has been granted 510(k) market clearance by the FDA for clot removal. Approval is based on clinical results from the TREVO 2 clinical trial presented at the 2012 European Stroke Conference in May. This technology demonstrated the highest rate of revascularization in a randomized embolectomy stroke device trial, and achieved significantly better post-procedure revascularization than the Merci Retriever (92% in the Trevo Retriever arm compared to 76.7% in the Merci Retriever arm). Other measures of performance also favored the Trevo Pro Retriever, including improvement in the National Institutes of Health Stroke Scale (NIHSS) score, excellent composite safety endpoints and shorter hospital stays.