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Next-generation stent retriever receives FDA clearance
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Cerenovus, a Johnson and Johnson company, announced its next-generation stent retriever to capture and remove blood clots from the brain in patients with ischemic stroke has received 510(k) clearance from the FDA.
The stent retriever (EmboTrap II, Cerenovus) restores blood flow by gripping and retrieving clots with use of minimal compression, which helps prevent future complications, according to a press release from the company.
Results from the ARISE II study were submitted with the application to the FDA. As Cardiology Today’s Intervention previously reported, patients with anterior and posterior circulation proximal large vessel occlusion who had an acute ischemic stroke and underwent revascularization with a novel device had high rates of reperfusion and favorable outcomes.
"Mechanical thrombectomy with newer generation devices is increasingly becoming standard treatment for acute ischemic stroke," Osama Zaidat, MD, MS, FAHA, FAAN, medical director of neuroscience and stroke at Mercy Health-St. Vincent’s Hospital in Toledo, Ohio, said in the press release. "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 company announced in July that the first U.S. patients have been treated with the device.
Disclosures: The ARISE II study was sponsored by Neuravi. Zaidat reports he is a consultant for Neuravi, now part of Cerenovus.
Editor's Note: This article was updated on July 24, 2018 with additional information from the company.