Enrollment Completed in ARISE II Pivotal Trial for Neuravi's EmboTrap II Revascularization Device
February 22, 2017—Neuravi announced completion of enrollment ahead of schedule in the company’s ARISE II international clinical trial assessing the safety and effectiveness of its EmboTrap II revascularization device, which is a stent retriever platform for the treatment of acute ischemic stroke. Neuravi, which is based in Ireland, advised that data from the pivotal ARISE II (Analysis of Revascularization in Ischemic Stroke With EmboTrap) study will be submitted as part of an application to the US Food and Drug Administration for market clearance of the device in the United States.
According to the company, the ARISE II study enrolled 228 patients at 19 sites across the United States and Europe. Sam Zaidat, MD, is the study’s Principal Investigator and Professor Tommy Andersson, MD, is the European Principal Investigator.
In the company's press release, Dr. Zaidat commented, “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. 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.”
Investigator Raul Nogueira, MD, added, “Evaluating new technology is an important part of advancing stroke treatment and we are enthusiastic about our experience in the ARISE II trial. 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 Neuravi's dual-layer stent-like structure. In September 2016, Neuravi announced that the EmboTrap II revascularization device received CE Mark approval and is commercially available in Europe. The device has been available in the United States for investigational use only, stated the company.