Neuravi has announced that the Tennessee Interventional and Imaging Associates at Erlanger Medical Center in Chattanooga, USA, have treated the first patient in an international clinical trial assessing safety and effectiveness of the EmboTrap Revascularisation Device, a novel stent retriever for the treatment of acute ischaemic 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 US Food and Drug Administration (FDA) for approval for the device.
The ARISE II study will enrol 210 patients in up to 25 sites across Europe and the United States. Sam Zaidat, Stroke and Neuroscience Medical Director of St Vincent Mercy Hospital, Toledo, Ohio and Tommy Andersson of the Karolinska Institute in Stockholm, Sweden are the US and European principal investigators of the study. Neurologists Jeff Saver of UCLA Medical Center in Los Angeles, and Heinrich Mattle 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 ischaemic stroke, we are looking for ways to further improve patient care through new technology, better techniques, and streamlined systems,” stated 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 centre is a Joint Commission-certified Comprehensive Stroke Centre 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, 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. ”
According to Neuravi, the design of the EmboTrap thrombectomy device is informed by extensive research on a full range of clots that cause ischaemic 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.