CERENOVUS, a Johnson & Johnson company that was built by combining Pulsar Vascular, Neuravi, and Codman Neuro’s neurological business, won FDA clearance for the EMBOTRAP II Revascularization Device. The stent retriever is used to pull blood clots from the brain, restoring blood flow and hopefully preventing the terrible consequences of a stroke.
The device, intended to be used within eight hours of initial stroke symptoms, is designed to apply as little pressure on the clot as possible in an attempt to avoid breaking it up into smaller parts, while confidently grabbing it to make sure it is removed completely.
Here’s some more info, according to the company:
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.”