Data from ARISE II Will Be Submitted to FDA in support of Market Clearance for EmboTrap in the U.S.
Galway, Ireland — Neuravi, a company dedicated to improving clinical outcomes for stroke patients, announced today that the Tennessee Interventional and Imaging Associates at Erlanger Medical Center in Chattanooga, Tenn., have treated the first patient in an international clinical trial assessing safety and effectiveness of the EmboTrap® Revascularization Device, a novel stent retriever 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 approval for the device.
The ARISE II study will enroll 210 patients in up to 25 sites across Europe and the United States. Sam Zaidat, M.D., Stroke and Neuroscience Medical Director of St. Vincent Mercy Hospital, Toledo, Ohio and Professor Tommy Andersson, M.D., Ph.D., of the Karolinska Institute in Stockholm, Sweden are the U.S. and European principal investigators of the study. Neurologists Jeff Saver, M.D., of UCLA Medical Center in Los Angeles, Calif. and Heinrich Mattle, M.D., of Inselspital in Bern, Switzerland, serve on the study’s initiating Executive Steering Committee.
“Stroke care has entered a new age. Now that multiple trials have demonstrated the value of endovascular therapy for treating acute ischemic stroke, we are looking for ways to further improve patient care through new technology, better techniques, and streamlined systems,” stated Dr. Zaidat. “The ARISE II trial is the first IDE clinical trial to evaluate innovative stent retriever technology in this new era for stroke.”
The Southeast Regional Stroke Center at Erlanger Medical Center was the first of the ARISE II sites to treat a patient as part of the trial. The center is a Joint Commission-certified Comprehensive Stroke Center that has played a leadership role in international clinical trials for stroke treatment.
“We are pleased to treat the first patient in this international trial of a cutting edge technology that may offer advantages over currently available devices,” said Blaise Baxter, M.D., chief of radiology at Erlanger. “Evaluating new technology with the goal of improving patient outcomes is all part of our effort to deliver the best patient care possible. ”
Following a stroke, rapid intervention is critical. Recent highly positive multinational clinical trials have demonstrated the benefit of acute endovascular intervention to remove the clot and rapidly restore blood flow to the brain. Physicians use minimally invasive thrombectomy devices, also known as ‘stent retrievers’, to perform these life-saving procedures.1 The Cleveland Clinic recently recognized stent retrievers as one of the top 10 medical innovations for 2016.
The design of the EmboTrap thrombectomy device is informed by extensive research on a full range of clots that cause ischemic stroke. With this foundation of research, the EmboTrap device is engineered to retrieve and retain the clot with a proprietary dual-layer stent-like structure while restoring blood flow to the brain. The device’s integrated distal protection zone is designed to reduce the risk of fragments of clot escaping during retrieval, which could cause additional harm to the patient.
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.2 Approximately one million Europeans3 and 700,000 Americans suffer ischemic strokes each year.4
“Working to improve clinical outcomes in stroke is central to Neuravi’s mission, and we are committed to investing in clinical research in order to deliver advanced technologies and new clinical tools to physicians,” said Mairsil Claffey, vice president of Clinical, Regulatory & Quality for Neuravi. “We are honored to be working with an esteemed group of global leaders in stroke treatment as part of the ARISE II trial.”
Based in Galway, Ireland, Neuravi is dedicated to improving clinical outcomes for stroke patients. The company’s initial stroke therapy platform, the EmboTrap Revascularization Device, is CE marked and commercially available in Europe. The device is 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.