Neuravi said today it enrolled the 1st patient in a clinical trial of its novel EmboTrap revascularization stent retriever device for treating acute ischemic stroke.
Data from the study will be submitted as part of Neuravi’s FDA premarket approval application, the Ireland-based company said.
“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. We are honored to be working with an esteemed group of global leaders in stroke treatment as part of the Arise II trial,” Neuravi clinical, regulatory & quality veep Mairsil Claffey said in prepared remarks.
The Embotrap device functions by capturing clots and allowing blood flow to resume immediately after the clot has been secured in patients who have experienced a stroke, CEO Eamon Brady told MassDevice.com in an interview in June.
The device is designed with a dual-layer stent-like structure as well as an integrated distal protection zone designed to reduce the risk of fragments of the clot dislodging during retrieval, the company said.
“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. The Arise II trial is the first IDE clinical trial to evaluate innovative stent retriever technology in this new era for stroke.” principal investigator Dr. Sam Zaidat of Toledo, Ohio’s St. Vincent Mercy Hospital said in a press release.
The Arise II study is slated to enroll 210 patients at 25 sites across Europe and the U.S. The 1st patient in the trial was enrolled at the Southeast Regional Stroke Center at Erlanger Medical Center
“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. Evaluating new technology with the goal of improving patient outcomes is all part of our effort to deliver the best patient care possible,” Dr. Blaise Baxter of Erlanger Medical Center said in a prepared statement.
Last month, Neuravi launched its EmboTrap minimally invasive thrombectomy device for the treatment of acute ischemic stroke in Europe.
The EmboTrap won CE Mark approval in the European Union in late 2014. The device is being sold and distributed in Belgium, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Norway, Spain, Sweden and Switzerland, Neuravi said.