FDA Clears Embotrap II for Ischemic Stroke Treatment

Embotrap II Revascularization Device, a stent retriever designed to capture and retrieve blood clots from the brain following ischemic stroke, received 510(k) clearance from the US Food and Drug Administration (FDA).

The mechanical thrombectomy device, which is manufactured by Cerenovus, a part of the Johnson & Johnson Medical Devices Companies, helps quickly restore blood flow to stroke-affected parts of the brain by removing thrombus.

The Embotrap II Revascularization Device is indicated for use within 8 hours of stroke symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment with Embotrap II.

"Embotrap II is the product of deep collaboration between engineers and clinicians to better understand the science of blood clot, what causes them to form and how a mechanical thrombectomy device can interact with them to help improve outcomes," Daniella Cramp, Worldwide President, Cerenovus, said in a statement. "Cerenovus is committed to advancing treatment with evidence-based solutions so that fewer and fewer people are affected by the ravages of stroke."

The 510(k) application included results from the ARISE II (Analysis of Revascularization in Ischemic Stroke with Embotrap^® Device) study. This study included 228 patients with large vessel occlusions and moderate to severe neurological deficits at 11 US and 8 European sites. The study found that neurointerventional stroke physicians successfully restored blood flow in 80.2% of patients (95% CI; 74%—85%; P value, <0.0001) within 3 passes and in 51.5% of patients within a single pass.

"Mechanical thrombectomy with newer generation devices is increasingly becoming standard treatment for acute ischemic stroke," said Osama Zaidat, MD, Stroke and Neuroscience Medical Director of St. Vincent Mercy Hospital, and lead author of the ARISE II study.

In the ARISE II study, after 90 days, 67% of patients were functionally independent. At the 90-day follow-up, all-cause mortality was 9%.

"The Embotrap II Device with its high first pass rate and its ability to address such a broad range of clot is a crucial step forward for stroke treatment in America," said Zaidat.

The Embotrap II was previously approved for use in Europe, where more than 3,000 patients have been treated.

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