Cerenovus Receives FDA Nod for EMBOTRAP II

Johnson & Johnson’s Cerenovus unit has received an FDA nod to market the EMBOTRAP II Revascularization Device. The device is a next generation stent retriever used to capture and remove life-threatening blood clots from the brain following an ischemic stroke.

The EMBOTRAP II Device is designed to rapidly restore blood flow by gripping and retrieving clots within the neurovasculature, with minimal compression, protecting against further complications. The device is indicated for use within eight hours of stroke symptom onset.

In the ARISE II study, which was submitted as part of the 510(k) application to FDA, neurointerventional stroke physicians were able to restore blood flow in 80 percent 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 were functionally independent. The study included 228 patients with large vessel occlusions and moderate to severe neurological deficits.

"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, which was published in the peer-reviewed journal, Stroke, earlier this year. "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."

The New Brunswick, N.J.-based J&J picked up Cerenovus when its DePuy Ireland Unlimited company acquired Neuravi for an undisclosed sum. Other firms with stent retrieval devices include, Stryker and Medtronic.

Kalamazoo, MI-based Stryker received a nod from the FDA for its Trevo retrieval devices about four years ago. Stryker gained access to Trevo through its $135 million acquisition of Cocentric Medical. Dublin-based Medtronic was able gain a foothold into the stent retrieval market through its $46 billion acquisition of Covidien in 2014. Covidien developed Solitaire, which gained approval in 2012. FDA expanded the approval of the Solitaire device to treat patients with acute ischemic stroke.