Earlier this week, Stryker announced FDA 510(k) clearance for the company’s Trevo Pro Retriever (Stryker Corp.), a stent-based device used to retrieve clots from the neurovasculature in acute ischemic stroke (AIS). The clearance makes the Trevo just the fourth mechanical thrombectomy device to receive FDA approval for AIS, along with the Merci Retriever (Concentric Medical Inc./Stryker Corp.), the Penumbra System (Penumbra Inc.), and the Solitaire FR Revascularization Device (Covidien), which received approval in March 2012.
FDA clearance for the Trevo Pro came on the heels of the TREVO 2 trial results presented in May at the 2012 European Stroke Conference. The trial randomized 178 individuals for treatment with either the Trevo Pro or the Merci Retriever following acute ischemic stroke. Results demonstrated significantly greater revascularization rates for the Trevo Pro compared to the Merci (86.4% vs. 60%). Functional outcomes were also improved with Trevo Pro, with 40% of patients having a modified Rankin score of two or less in the Trevo Pro arm of the study, compared to 21.8% in the Merci arm. Other measures that favored the Trevo Pro included National Institutes of Health Stroke Scale scores and hospital length of stay.
Thus far, 2012 has been a year of accelerated growth for the interventional stroke device market, which previously saw no new entrants for nearly five years. The Trevo Pro, along with the Solitaire FR, marks the second thrombectomy device to receive FDA approval in less than six months. Similar devices for ischemic stroke have already received CE mark approval in Europe, including the Mindframe Flow (MindFrame), ReStoreThrombectomy Microcatheter (Reverse Medical), and the Revive SE (Johnson & Johnson/Codman & Shurtleff).
Stay tuned as we continue to monitor this evolving market.