CERENOVUS, part of the Johnson & Johnson Medical Devices Companies, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EMBOTRAP II Revascularization Device, a next generation stent retriever used to capture and remove life-threatening blood clots from the brain following an ischemic stroke.
Stroke strikes nearly 800,000 Americans each year, and is a leading cause of disability and the fifth leading cause of death.1 For stroke patients, the difference between life and death, and functional independence or disability, is tied to timely restoration of blood flow to the oxygen-starved brain after a stroke occurs.
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 specific design of this mechanical thrombectomy device, which is indicated for use within eight hours of stroke symptom onset, is the result of extensive research into the science of clot.
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 device is also approved for use in Europe, where more than 3,000 patients have been treated.
“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,” said Daniella Cramp, Worldwide President, CERENOVUS. “CERENOVUS is committed to advancing treatment with evidence-based solutions so that fewer and fewer people are affected by the ravages of stroke.”
Indications for Use: The EMBOTRAP II Revascularization Device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within eight hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
1 Impact of Stroke (Stroke statistics). Stroke Treatment. http://www.strokeassociation.org/STROKEORG/AboutStroke/Impact-of-Stroke-Stroke-statistics_UCM_310728_Article.jsp#.Wvycyu4vzIV. Published June 6, 2016.