Route 92 Medical’s Monopoint Operating Platform Evaluated in Independent Study

July 25, 2022—Route 92 Medical, Inc. announced the publication of a multicenter study of the super large-bore ingestion of clot (SLIC) technique with the company’s Monopoint operating platform. The study provides a large reported series using 088 aspiration catheter technology for intracranial thrombectomy. The investigator-initiated study was conducted without input from Route 92 Medical.

According to the company, results from 33 consecutive patients showed 82% first-pass efficacy and 100% success in reaching the intracranial occlusion with Route 92 Medical’s HiPoint 88 0.088-inch inner diameter super-bore catheter with 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.

The findings were published by Francesco Massari, MD, et al online in the Journal of NeuroInterventional Surgery (JNIS).

Route 92 Medical stated that the SLIC study 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 the assembly of the Monopoint operating platform, which is a telescoping neurointervention delivery system comprised of the company’s 8-F Base Camp sheath, the HiPoint 88 super-bore catheter, and the Tenzing delivery catheters, all of which can be controlled from a single operating zone. These three devices have received FDA 510(k) clearance for the introduction of interventional devices into the peripheral and neurovasculature. They are not indicated or cleared by the FDA to treat stroke, noted the company.

The use of the HiPoint catheter for stroke treatment is currently being evaluated in the United States under an FDA-approved investigational device exemption study named SUMMIT MAX. The data presently reported in JNIS by Massari et al are separate from SUMMIT MAX.

“This initial experience across three experienced, high-volume neurointerventional centers using the SLIC technique 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,” commented Ajit S. Puri, MD, in the company’s press release. Dr. Puri, the corresponding author of the study, is Professor of Radiology, Neurosurgery, and Neurology at the University of Massachusetts Medical Center in Worcester, Massachusetts.

“Results are encouraging and give reason to continue assessing the Monopoint platform as a potential tool for improved patient outcomes in stroke,” commented Dr. Pur

Tony Chou, Founder and Chief Executive Officer of Route 92 Medical, stated in the press release, “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.” In 2021, findings from SUMMIT NZ were published online by James Caldwell, MD, et al in JNIS.

Mr. Chou continued, “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.”