ARISE II Results Presented for Cerenovus' Embotrap for Ischemic Stroke
January 25, 2018—Cerenovus, part of the Johnson & Johnson Medical Devices Companies, announced that data from the ARISE II clinical trial, an analysis of revascularization in ischemic stroke with the company's Embotrap device, were presented by Osama Zaidat, MD, at ISC 2018: the International Stroke Conference 2018 held January 24–26 in Los Angeles, California.
The company has submitted the ARISE II study data as part of its application to the US Food and Drug Administration for marketing clearance of the Embotrap device in the United States. The device has been approved for use in Europe. The Embotrap platform was developed by Neuravi Limited, which Cerenovus acquired in April 2017.
The Embotrap device, which is a next-generation stent retriever designed to retrieve a broad range of clot types from the brain after an ischemic stroke, demonstrated high success rates in restoring blood flow and patients achieved high rates of functional independence.
According to Cerenovus, the multicenter ARISE II study enrolled 228 patients to assess the safety and effectiveness of the Embotrap device. Patients eligible for the study had large vessel occlusions and moderate to severe neurologic deficits within 8 hours of symptom onset.
Neurointerventional stroke physicians in the ARISE II trial were able to restore blood flow in 80% of patients treated with the Embotrap device within three passes (with a reperfusion grade of modified treatment in cerebral infarction [mTICI] ≥ 2b). By the end of the procedure, vessels were opened in 93% of patients. In addition, substantial reperfusion (mTICI 2c or 3) was achieved with just a single pass in half the patients. At the 90-day follow-up, 67% were functionally independent. Overall, the study successfully met the prespecified endpoints.
In the company's press release, Dr. Zaidat commented, "I believe the Embotrap device will be an important new option for treating stroke patients. The study results look strong with very encouraging outcomes achieved for reperfusion, modified Rankin Scale, speed to revascularization, as well as the rate of first-pass success."