Route 92 Begins SUMMIT RISE Postmarket Study of its Neurovascular Interventional Portfolio

March 9, 2026—Route 92 Medical, Inc. announced the commencement of the SUMMIT RISE postmarket study evaluating the performance of the company’s portfolio of neurovascular interventional solutions across a variety of stroke scenarios and vessel sizes.

According to the company, SUMMIT RISE is a prospective, multicenter, open-label, core-lab–adjudicated study assessing real-world performance of the Route 92 Medical reperfusion systems. The study is expected to enroll 500 patients at 50 clinical centers, including academic medical centers and community hospitals.

The study is being led by Coprimary Investigators Sunil Sheth, MD; Christopher Kelner, MD; and Albert Yoo, MD. Dr. Sheth is Associate Professor and Director, Vascular Neurology Program at the McGovern Medical School at University of Texas, Houston in Houston, Texas. Dr. Kelner is a neurosurgeon at Mount Sinai Health System in New York, New York. Dr. Yoo is Medical Director and Director of Research and Technology, Medical City Texas Stroke Institute in Plano, Texas.

“The SUMMIT RISE study is designed to collect and analyze data prospectively, and review all cases through an independent adjudication process, to impartially evaluate the effectiveness of Route 92 Medical’s devices across a range of patient presentations, clinician experience levels, and health system settings,” commented Dr. Sheth in the company’s press release. “We hope these data elucidate insights that support technique optimization, ultimately improving device performance and patient outcomes.”

Robert Regenhardt, MD, who is Assistant Professor of Neurology at UTHealth McGovern Medical School, enrolled the first patient in SUMMIT RISE.

Dr. Regenhard stated in the press release, “New medical technologies require rigorous, independently developed, real-world evidence to support their widespread adoption. The data we collect in this study will enable the refinement of clinical best practices for stroke treatment.”