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 surgery, today announced the release of initial results from the SUMMIT NZ trial, a prospective, single-arm, multicenter trial evaluating the proprietary Monopoint operating platform. Results from the first 45 patients demonstrated that the Monopoint platform produced an 80% first-pass effect (FPE1) with primary use of the HiPoint™ 88 (.088in ID) catheter, a super-bore catheter designed to achieve systematically the proximal middle cerebral artery (MCA). The Route 92 HiPoint 88 Aspiration Catheter successfully reached the proximal MCA (M1 segment) in 100% of attempted cases. The results have been published in the Journal of NeuroInterventional Surgery online2.
“The Monopoint OR platform with HiPoint 88 catheters provided a step change in first pass efficiency in the SUMMIT NZ trial, signaling clear potential for improved patient outcomes given the importance of remove thrombi to save time and save the brain,” said Dr James Caldwell, attending physician at Auckland Hospital and first author of the paper. “The platform is designed to improve catheter deliverability, providing the benefit of greater simplicity for the operating physician to efficiently perform thrombectomy for patients.”
SUMMIT NZ is a prospective, multicentre, single-arm trial that recruited patients across New Zealand. The trial evaluated the safety and clinical effectiveness of the new Monopoint operating platform in delivering super-bore and large-bore (0.088 inch ID and 0.070 inch ID) HiPoint suction catheters to the M1. The trial is the largest reported to date using 088 suction catheter technology for intracranial thrombectomy, offering an encouraging signal that superbore suction catheters can increase first-pass reperfusion (mTICI ≥2b) .
“An increase in first-pass effect is strongly correlated with superior outcomes and reduced disability1. Route 92’s new platform greatly facilitates delivery of the super-bore HiPoint 88 catheter to the target vessel and, by properly sizing the catheter to the clot, allows for the application of a higher suction force which appears to increase the first pass effect,” said Warren Kim, MD, PhD, consulting medical director of Route 92 Medical.” These initial results from SUMMIT NZ establish a solid foundation for establishing Level 1 evidence of patient benefit, and we look forward to completing Route 92 Medical’s SUMMIT MAX randomized clinical trial, comparing the Monopoint operating platform to the current largest bore catheter system on the market. ”
Route 92 Medical’s HiPoint Catheters, Tenzing® Catheters and Base Camp® Sheath System have received US FDA 510(k) clearance for neurovascular access.
Each year, strokes affect around 16 million people and kill around 6 million people worldwide. In the United States, more than 800,000 patients suffer from acute ischemic stroke each year, with an annual health care cost of $104 billion. Stroke is an urgent disease and without proper diagnosis and treatment, most patients suffer permanent disability or die. Recent data has proven that prompt intervention using specialized devices to restore blood flow to brain tissue can significantly reduce death and disability associated with acute stroke. Despite recent advances in these life-saving endovascular treatments, only about 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 surgery through advanced engineering and innovative product design. Founded by physicians, the development of thoughtful product solutions in collaboration with the world’s best clinicians is at the heart of our concerns. Our portfolio targets the greatest challenges of neurointervention to deliver meaningful solutions.
1Zaidat O, et al. First pass effect. A new measurement for stroke thrombectomy devices. Stroke 2018; 49: 660-666.
2Caldwell J, et al. Suction thrombectomy using a new 088 catheter and a specialized delivery catheter. Review ofNeuroInterventionalOperation 2021; Electronic publication.
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