Johnson & Johnson‘s (NYSE:JNJ) Cerenovus said today it won FDA 510(k) clearance for the Embotrap II revascularization device.
The Irvine, Calif.-based J&J division said that the device is designed to quickly restore natural blood flow by retrieving emboli within the vasculature of the brain, using minimal compression to protect against further complications.
Approval of the device came based on data from the Arise II study, in which investigators reported being able to restore blood flow in 80% of patients treated within three passes, and in approximately 50% within a single pass. More than 66% of patients were functionally independent at the 90-day follow up, Cerenovus said.
“Mechanical thrombectomy with newer generation devices is increasingly becoming standard treatment for acute ischemic stroke. 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,” Arise II study primary investigator Dr. Osama Zaidat of St. Vincent Mercy Hospital said in a prepared statement.
The company said that it previously won CE Mark approval in the European Union for the device, and has been used in more than 3,000 procedures so far.
“Embotrap II is the product of deep collaboration between engineers and clinicians to better understand the science of blood clot, what causes them to form and how a mechanical thrombectomy device can interact with them to help improve outcomes. Cerenovus is committed to advancing treatment with evidence-based solutions so that fewer and fewer people are affected by the ravages of stroke,” Cerenovus worldwide prez Daniella Cramp said in a press release.
Last month, a report emerged claiming that J&J’s Cerenovus would discontinue production of Codman pumps designed to deliver targeted chemotherapy to the liver for patients with liver cancer.
