Route 92 Medical’s SUMMIT RISE Study is Underway

Route 92 Medical Inc. has enrollment of the first patient in SUMMIT RISE, a prospective 500-patient real-world post-clearance study to evaluate the performance of its neurovascular interventional solutions across various stroke scenarios and vessel sizes. The study is expected to enroll patients at 50 clinical centers, including academic medical centers and community hospitals. 

“We developed our portfolio of complete neurovascular interventional systems with one goal—improving outcomes for patients being treated for acute ischemic stroke,” Route 92 Medical Founder/CEO Tony Chou, M.D., said. “Building from our prior studies and trials, including SUMMIT MAX, we expect SUMMIT RISE to give us comprehensive data across anatomies, physician users, devices, patients and clinical sites, enabling us to evaluate and collect wide-ranging data on the family of Route 92 Medical reperfusion systems including the HiPoint 88 reperfusion system, the only FDA-cleared super-bore catheter system for direct aspiration of large vessel occlusions in patients experiencing an acute ischemic stroke.”

SUMMIT RISE is a prospective, multi-center, open-label, core-lab-adjudicated study to assess real-world performance of the Route 92 Medical reperfusion systems. It is being led by co-primary investigators Sunil Sheth, M.D., associate professor and director of the Vascular Neurology Program at the McGovern Medical School at the University of Texas, Houston; Christopher Kelner, M.D., neurosurgeon at Mt. Sinai Health System; and Albert Yoo, M.D., medical director and director of Research and Technology, Medical City Texas Stroke Institute. 

“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,” stated Dr. Sheth, an associate professor of Neurology at UTHealth McGovern Medical School. “We hope these data elucidate insights that support technique optimization, ultimately improving device performance and patient outcomes.”

“New medical technologies require rigorous, independently developed, real-world evidence to support their widespread adoption,” added Robert Regenhardt, M.D., Ph.D., assistant professor of Neurology at UTHealth McGovern Medical School and the first to enroll a patient in SUMMIT RISE. “The data we collect in this study will enable the refinement of clinical best practices for stroke treatment.”

Route 92 Medical aims to improve outcomes for patients undergoing neurovascular intervention through cutting-edge engineering and innovative product design. Founded by physicians, the company collaborates with neurovascular clinicians to solve the biggest challenges in neurointervention and deliver solutions that promote clinical success.