FDA Clears Next-Generation Stent Retriever to Treat Ischemic Stroke
Cerenovus, part of the Johnson & Johnson Medical Devices Companies, announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Embotrap II revascularization device. The next-generation Embotrap stent retriever is used to capture and remove blood clots from the brain after an ischemic stroke.
The Embotrap II stent is indicated for mechanical thrombectomy within 8 hours of stroke symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV tPA) or who fail IV tPA therapy are candidates for treatment. The device is also approved for use in Europe.
According to the company, Embotrap II rapidly restores blood flow by gripping and retrieving clots within the neurovasculature with minimal compression, protecting against further complications.
Data from the multicenter ARISE II study were submitted as part of the 510(k) application to the FDA. In ARISE II, neurointerventional stroke physicians were able to restore blood flow in 80% of patients treated within three passes and in approximately half of the patients within a single pass. At the 90-day follow-up, more than two-thirds of the patients were functionally independent. The study included 228 patients with large vessel occlusions and moderate to severe neurological deficits.
ARISE II findings were presented by Osama Zaidat, MD, at ISC 2018: the International Stroke Conference 2018 held January 24–26 in Los Angeles, California. On April 11, primary results of the ARISE II study were published by Dr. Zaidat et al in Stroke (2018;49:1107-1115).
In the company's announcement, Dr. Zaidat commented, “Mechanical thrombectomy with newer-generation devices is increasingly becoming standard treatment for acute ischemic stroke. 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.” Dr. Zaidat is Stroke and Neuroscience Medical Director of St. Vincent Mercy Hospital in Toledo, Ohio.