Route 92 Medical’s Monopoint Reperfusion System Studied in Pivotal SUMMIT MAX Trial

February 8, 2022—Route 92 Medical, Inc., a medical technology company focused on acute ischemic stroke intervention, announced the first patient enrollment in its SUMMIT MAX clinical trial of the company’s next-generation Monopoint reperfusion system.

According to Route 92 Medical, SUMMIT MAX is a prospective, randomized controlled, pivotal trial that will evaluate the clinical efficacy and safety of the Monopoint system versus currently available aspiration catheter technology. The multicenter study will enroll up to 220 patients at 30 sites in the United States and New Zealand. The study’s principal investigators are Thanh Nguyen, MD; Ajit Puri, MD; and Guillerme Dabus, MD.

The study is intended to build on the recently published results of the SUMMIT NZ study and provide clinical evidence to support an application for FDA clearance.

The company reported that the first patient in the SUMMIT MAX trial was enrolled by Ben McGuinness, MD, at Auckland City Hospital in Auckland, New Zealand, which was followed by the first patient enrolled in the United States at West Virginia University Medicine in Morgantown, West Virginia.

“I am delighted to begin enrollment in the SUMMIT MAX study,” commented Dr. McGuinness in the company’s press release. “The early results from our initial experience with the Route 92 088 platform in the SUMMIT NZ Study demonstrated an 80% TICI 2b-3 first pass reperfusion rate. It is an exciting opportunity to evaluate the possibility of improving interventional stroke treatment, and I hope the results of this trial will benefit future stroke patients.”

Ansaar Rai, MD, who is Professor and Chair of the Neuroradiology Department at the Rockefeller Neuroscience Institute at West Virginia University Medicine, added, “We are happy to become the first United States site to enroll a patient in the SUMMIT MAX clinical trial evaluating the Monopoint system. Randomized clinical trials such as these offer high levels of evidence and are critical in advancing the field of endovascular stroke therapy.”