ARISE II Data Will Be Submitted to the FDA in Support of Market Clearance for EmboTrap in the U.S.
Galway, Ireland — 21 February 2017 — Neuravi, a company dedicated to improving clinical outcomes for stroke patients, today announced completion of enrollment in the company’s international clinical trial assessing the safety and effectiveness of the EmboTrap®II Revascularization Device, an advanced stent retriever platform for the treatment of acute ischemic stroke.
Data from the pivotal study, called ARISE II (Analysis of Revascularization in Ischemic Stroke with EmboTrap), will be submitted as part of an application to U.S. Food and Drug Administration (FDA) for market clearance of the device in the United States.
The ARISE II study enrolled 228 patients in 19 enrolling sites across the United States and Europe. Sam Zaidat, M.D., Stroke and Neuroscience Medical Director of St. Vincent Mercy Hospital in Toledo, Ohio, is the study’s principal investigator. Professor Tommy Andersson, M.D., Ph.D., of the Karolinska Institute in Stockholm, Sweden, is the European principal investigator of the study.
“The value of stent retrievers has been demonstrated by multiple positive trials. Now our focus has moved on to further refinements of mechanical thrombectomy that will yield better patient outcomes,” said Dr. Zaidat. “International cooperation has been excellent. I’m excited to be a part of the process to provide physicians and patients in the United States with access to the latest technology.”
The study enrolled ahead of schedule, with enrollment led by Dr. Hormozd Bozorgchami’s team at Oregon Health Sciences University in Portland and Dr. Marc Ribo’s team at Vall d’Hebron in Barcelona.
“Evaluating new technology is an important part of advancing stroke treatment and we are enthusiastic about our experience in the ARISE II trial,” said Raul Nogueira, M.D., director of Neuroendovascular Service at Grady Memorial Hospital at Emory University in Atlanta, where the final U.S. patient was enrolled. “As we continue to learn more about the clots that cause stroke, it is important that we have the best tools available to treat those occlusions.”
The EmboTrap platform is designed to restore blood flow to the brain by retrieving and retaining clot with a proprietary dual-layer stent-like structure.
“We’d like to thank the stroke center teams in the United States and Europe for their dedication and commitment to the ARISE II trial. In fully enrolling the ARISE II clinical trial, we are building a strong data set in support of our EmboTrap device as well as adding to the broader pool of stent retriever thrombectomy data for stroke treatment,” said Eamon Brady, Neuravi CEO. “Our vision is to be the therapy leader in acute ischemic stroke intervention and we will to continue to develop innovative therapy solutions to advance patient care.”
Ischemic strokes, caused by blockages in vessels supplying blood to the brain, account for 87% of all strokes and are a leading cause of death and disability. Approximately one million Europeans and 700,000 Americans suffer ischemic strokes each year.
Based in Galway, Ireland, Neuravi is dedicated to improving clinical outcomes for stroke patients. The company’s stroke therapy platform, the EmboTrap®II Revascularization Device, is CE marked and commercially available in Europe. The device has been available for investigational use only in the United States. Through its investment in the Neuravi Thromboembolic Initiative (NTI), Neuravi supports collaboration between engineers, clinicians and researchers to deepen the understanding of clot and occlusion dynamics, in order to improve patient outcomes in stroke. Neuravi is led by a team experienced in endovascular device development and global commercialization. More information can be found at www.neuravi.com.
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