June 6, 2022
SAN MATEO, Calif., June 06, 2022 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a private medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the publication of initial results of the SUMMIT NZ clinical trial, a single-arm, multi-center, prospective trial evaluating the proprietary Monopoint operating platform. Results from the first 45 patients demonstrated that the Monopoint platform yielded an 80% first pass effect (FPE1) with primary use of the HiPoint™ 88 (.088in ID) catheter, a super-bore catheter designed to consistently reach the proximal middle cerebral artery (MCA). The Route 92 HiPoint 88 aspiration catheter successfully reached the proximal MCA (M1 segment) in 100% of the cases attempted. The results were published in the Journal of NeuroInterventional Surgery online2.
“The Monopoint operating platform with HiPoint 88 catheters delivered a step change in first pass efficacy in the SUMMIT NZ trial, signaling clear potential for improved patient outcomes given the importance of clearing thrombus to save time and save brain,” said Dr. James Caldwell, attending physician at Auckland City Hospital and the paper’s first author. “The platform is designed to improve catheter deliverability offering the advantage of greater simplicity for the operating physician to efficiently perform thrombectomy for patients.”
SUMMIT NZ is a prospective, multi-center, single-arm trial that enrolled patients across New Zealand. The trial evaluated the safety and clinical efficacy of the novel Monopoint operating platform in delivering the super-bore and large-bore HiPoint aspiration catheters (0.088in ID and 0.070in ID) to the M1. The trial is the largest reported to date using 088 aspiration catheter technology for intracranial thrombectomy, offering an encouraging signal that super-bore aspiration catheters may increase first pass reperfusion (mTICI ≥2b).
“An increase in first pass effect is highly correlated with superior outcomes and reduction in disability1. Route 92’s novel platform makes it dramatically easier to deliver the HiPoint 88 super-bore catheter to the target vessel and, by right-sizing the catheter to the clot, allows the application of higher aspiration force which appears to increase first pass effect,” said Warren Kim, MD, PhD, Consultant Medical Director of Route 92 Medical. “These initial SUMMIT NZ results establish a strong foundation for building level 1 evidence of patient benefit, and we look forward to completing Route 92 Medical’s randomized clinical trial SUMMIT MAX, comparing the Monopoint operating platform against the current largest bore catheter system on the market.”
Route 92 Medical’s HiPoint catheters, Tenzing® catheters and Base Camp® sheath system have received U.S. FDA 510(k) clearance for neurovascular access.
Each year, strokes affect about 16 million people and kill an estimated 6 million people globally. In the United States, more than 800,000 patients suffer from acute ischemic stroke each year, with an annual healthcare cost of $104 billion. Stroke is a critically time-sensitive disease and without appropriate diagnosis and treatment, most patients suffer permanent disability or death. Recent data has proven that rapid intervention using specialized devices to restore blood flow to brain tissue can dramatically reduce the death and disability associated with acute stroke. Despite recent advances in these life-saving endovascular treatments, only ~10% of eligible stroke patients are treated with intervention today.
About Route 92 Medical, Inc.
Route 92 Medical is on a mission to improve outcomes for patients undergoing neurovascular intervention through cutting-edge engineering and innovative product design. Founded by physicians, developing thoughtful product solutions in collaboration with the world’s leading clinicians is at our core. Our portfolio takes aim at the biggest challenges in neurointervention to deliver meaningful solutions.