Route 92 Medical has today announced the first enrolment in SUMMIT RISE—a 500-patient, real-world, post-clearance study evaluating the performance of the company’s portfolio of neurovascular interventional solutions across a variety of stroke scenarios and vessel sizes. The study is expected to enrol patients at 50 clinical sites, including academic medical centres and community hospitals.
“The SUMMIT RISE study is designed to collect and analyse 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,” said Sunil Sheth (UTHealth McGovern Medical School, Houston, USA), co-primary investigator for SUMMIT RISE. “We hope these data elucidate insights that support technique optimisation, 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 (UTHealth McGovern Medical School, Houston, USA), the first physician to enrol a patient in SUMMIT RISE. “The data we collect in this study will enable the refinement of clinical best practices for stroke treatment.”
SUMMIT RISE is a prospective, multicentre, open-label, core lab-adjudicated study assessing the real-world performance of Route 92’s reperfusion systems. It is being led by Sheth alongside co-primary investigators Christopher Kellner (Mount Sinai Health System, New York, USA) and Albert Yoo (Medical City Texas Stroke Institute, Plano, USA).
“We developed our portfolio of complete neurovascular interventional systems with one goal—improving outcomes for patients being treated for acute ischaemic stroke,” commented Tony Chou, founder and chief executive officer (CEO) of Route 92. “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 [US Food and Drug Administration]-cleared super-bore catheter system for direct aspiration of large vessel occlusions in patients experiencing an acute ischaemic stroke.”
