Route 92 Medical Completes Enrollment in SUMMIT MAX RCT of HiPoint Reperfusion Catheters

February 21, 2024—Route 92 Medical, Inc., a medical technology company dedicated to neurovascular intervention, announced the completion of enrollment in its 250-patient SUMMIT MAX clinical trial. The trial is evaluating the safety and effectiveness of the company’s HiPoint 88 and HiPoint 70 reperfusion catheters as part of its Monopoint reperfusion system.

According to Route 92 Medical, it is the first company to complete enrollment in a trial studying the safety and efficacy of a “super-bore” aspiration catheter with at least a 0.088-inch inner diameter for the treatment of a large vessel occlusion.

The National Principal Investigators are Thanh N. Nguyen, MD; Ajit Puri, MD; and Guilherme Dabus, MD.

“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,” commented Dr. Nguyen in the company’s press release. “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.”

Dr. Nguyen, who is Professor of Neurology, Neurosurgery, and Radiology at Boston University School of Medicine in Boston, Massachusetts, continued, “SUMMIT MAX is the first FDA-approved aspiration thrombectomy trial which is randomized. RCTs 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 robust evidence to guide clinical decision-making.”

Route 92 Medical stated that the HiPoint 88 reperfusion catheter is designed to quickly and efficiently reperfuse occluded vessels to treat patients experiencing 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, noted the company.

Tony Chou, MD, who is Founder and Chief Executive Officer of Route 92 Medical, stated in the press release, “Route 92 Medical is leading the way in neurovascular innovation technology, bringing clinicians complete solutions designed to improve endovascular thrombectomy procedure times and outcomes. RCTs are the hardest trials 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.”

Finally, Dr. Tony Chou advised, “This study will provide the safety and effectiveness data we need to support our 510(k) application to the US FDA and other global regulatory bodies.”