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Embotrap II Cleared for Treating Ischemic Strokes
Devices Submissions and Approvals
The FDA granted marketing clearance to Cerenovus’ Embotrap II for treatment of ischemic stroke, a mechanical thrombectomy device designed to retrieve blood clots from the brain.
The 510(k) application included results from the ARISE II trial of 228 patients at 11 U.S. and 8 European sites. The study found that physicians successfully restored blood flow in 80.2 percent of patients within 3 passes and in 51.5 percent of patients within a single pass.
The stent retriever can be used up to eight hours after the patient experiences stroke symptom onset and patients ineligible for IV tissue plasminogen activator therapy are candidates for treatment.