July 25, 2022
SAN MATEO, Calif., July 25, 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 an investigator-initiated, multicenter SLIC study of its proprietary Monopoint® operating platform showing 82% first pass efficacy. Results from 33 consecutive patients also demonstrated 100% success in reaching the intracranial occlusion with the company’s HiPoint™ 88 (.088in ID) super-bore catheter, a groin-to-recanalization time of 20 minutes, mean groin to clot contact time of 14 minutes, and no serious adverse events or emboli in a new territory (ENTs). Results were published in the Journal of NeuroInterventional Surgery online.1
The SLIC study, which was conducted without input from Route 92 Medical, was a retrospective review of three comprehensive stroke center databases, evaluating the initial clinical feasibility, safety, and efficacy of the Monopoint operating platform using the SLIC technique for stroke. The SLIC technique entails telescopic assembly of the Monopoint operating platform by using the 8F Base Camp® Sheath, HiPoint 88 (088in ID) super-bore catheter, and Tenzing® delivery catheter. The study is the largest reported series using 088 aspiration catheter technology for intracranial thrombectomy.
Route 92 Medical’s HiPoint catheters, Tenzing catheters and Base Camp sheath system have received U.S. FDA 510(k) clearance for introduction of interventional devices into the peripheral and neuro vasculature. These devices are not indicated or cleared by the FDA to treat stroke. The use of the HiPoint catheter for stroke treatment is currently being evaluated in the United States under an FDA-approved investigational device exemption (IDE) study named SUMMIT MAX. The data reported on here are apart from SUMMIT MAX.
“This initial experience across three experienced, high-volume neurointerventional centers using the super large-bore ingestion of clot technique (SLIC) for treatment of acute ischemic stroke due to large vessel occlusion shows high rates of complete clot ingestion resulting in excellent first pass efficacy and reperfusion rates using the HiPoint 88 super-bore catheter,” said Dr. Ajit S. Puri, Professor of Radiology, Neurosurgery and Neurology at the University of Massachusetts Medical Center and the corresponding author of the paper. “Results are encouraging and give reason to continue assessing the Monopoint platform as a potential tool for improved patient outcomes in stroke.” 2
“The conclusion of this analysis reinforces and builds upon the recent results of the SUMMIT NZ trial, which showed an 80% first pass effect with primary use of our HiPoint 88 catheter in the first 45 patients,” 2 said Tony Chou, Founder and Chief Executive Officer of Route 92 Medical. “Evidence continues to indicate that our novel Monopoint operating platform, which is designed to facilitate simple delivery of the HiPoint 88 super-bore catheter to the target vessel and allow the application of high aspiration force, appears from these data to increase first pass effect. We look forward to completing our randomized clinical trial SUMMIT MAX, comparing the Monopoint operating platform against the current largest bore catheter system cleared by the FDA for the treatment of acute ischemic stroke.”
About Monopoint Operating Platform
The Monopoint operating platform is a telescoping neurointervention delivery system comprised of the Base Camp Sheath, the HiPoint catheters and the Tenzing delivery catheters, all of which can be controlled from a single operating zone.
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.
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.