First Patients Treated With Next-Generation Embotrap II Stent Retriever
Cerenovus, part of the Johnson & Johnson Medical Devices Companies, announced the launch of its Embotrap II revascularization device at the Society of NeuroInterventional Surgery's 15th Annual Meeting held July 23–26 in San Francisco, California. In May, the company announced FDA clearance to market the next-generation Embotrap II stent retriever for mechanical thrombectomy of blood clots from the brain after an ischemic stroke. The Embotrap II device is also approved for use in Europe.
According to Cerenovus, the Embotrap II features a dual-layer design that engages and grips stroke-inducing blood clots with a unique action that allows the interventionalist to maintain engagement and control of the clot with minimal compression during removal. It is indicated for use within 8 hours of symptom onset.
The company advised that the first patients have been treated with the device since it became commercially available in the United States. Andrew DeNardo, MD, an interventional neuroradiologist with Goodman Campbell Brain & Spine, along with John Scott, MD, Daniel Sahlein, MD, and Richard Paulsen, MD, recently performed thrombectomies with the device at Indiana University Health Methodist Hospital and St. Vincent Hospital in Indianapolis, Indiana.
In the ARISE II study, use of the EmboTrap II device restored blood flow in 80% of patients treated within three passes and in about half of patients within a single pass. At the 90-day follow-up, more than two-thirds of 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. In April, primary results of the ARISE II study were published by Dr. Zaidat et al in Stroke (2018;49:1107–1115).