Patient Enrollment Complete in Study of Route 92 Medical’s HiPoint Reperfusion Catheters

Route 92 Medical Inc. has completed enrollment in its 250-patient SUMMIT MAX clinical trial evaluating the safety and effectiveness of its HiPointTM 88 and HiPoint 70 Reperfusion Catheters as part of the Monopoint Reperfusion System.

Route 92 Medical claims to be the first company to complete enrollment in a trial studying the safety and efficacy of a “super-bore” aspiration catheter with at least an 0.088 inch inner diameter for treating a large vessel occlusion, the cause of many acute ischemic strokes. 
 
“SUMMIT MAX is a pivotal, randomized controlled trial (RCT) investigating the safety and efficacy of an 0.088-inch aspiration catheter, a technology advancement the clinical community has believed important to improve stroke care for many years,” said Dr. Thanh N. Nguyen, professor of Neurology, Neurosurgery and Radiology at Boston University School of Medicine and co-national principal investigator along with Drs. Ajit Puri and Guilherme Dabus. “In a field where time is brain, systems of devices that could improve the quality of reperfusion, reduce procedure times and simplify the procedure are needed. SUMMIT MAX is the first FDA-approved aspiration thrombectomy trial which is randomized. Randomized controlled trials provide the best clinical science and the SUMMIT MAX Trial compares the Route 92 Medical Monopoint System to the largest commercially available conventional aspiration system. The data from SUMMIT MAX will provide evidence to guide clinical decision-making.”
 
The HiPoint 88 Reperfusion Catheter is designed to quickly and efficiently reperfuse occluded vessels to treat patients suffering an acute ischemic stroke. As part of the Monopoint Reperfusion System, the HiPoint Catheters are advanced from a single point of control and are delivered by Tenzing 8 or Tenzing 7 Catheters to provide a streamlined unit that is designed to track through vascular curvatures without catching side branches utilizing a one-piece advancement technique. The telescoping design of the Monopoint Reperfusion System, with tapered components, is designed to reduce ledge effect, enabling atraumatic movement through tortuous anatomy.
 
“Route 92 Medical is leading the way in neurovascular innovation technology, bringing clinicians complete solutions designed to improve endovascular thrombectomy procedure times and outcomes. Randomized controlled trials are the hardest for study sponsors to manage and enroll. The completion of this study demonstrates our commitment to advancing clinical science and providing our interventionalist customers with the most complete portfolio of reperfusion solutions available,” Route 92 Medical Founder/CEO Tony Chou, M.D., said. “This study will provide the safety and effectiveness data we need to support our 510(k) application to the U.S. FDA and other global regulatory bodies.”
 
Based in San Mateo, Calif., Route 92 Medical collaborates with neurovascular clinicians to solve challenges in neurointervention and deliver solutions that promote clinical success.