Route 92 Medical’s 088 Monopoint Operating Platform Studied in SUMMIT NZ Trial

June 6, 2022—Route 92 Medical, Inc., a medical technology company focused on neurovascular intervention, announced the publication of the initial results from the SUMMIT NZ clinical trial. The single-arm, multicenter, prospective trial is evaluating the company’s Monopoint operating platform.

According to the company, results from the first 45 patients in the SUMMIT NZ trial demonstrated that the Monopoint platform yielded an 80% first pass effect (FPE) with primary use of the company’s HiPoint 88, a 0.088-inch inner diameter (ID) catheter. The super-bore HiPoint 88 catheter is designed to consistently reach the proximal middle cerebral artery (MCA).

Route 92 Medical reported that the HiPoint 88 aspiration catheter successfully reached the proximal MCA (M1 segment) in 100% of the cases attempted in SUMMIT NZ. The results were published online by James Caldwell, MD, FRANZCR, et al in Journal of NeuroInterventional Surgery.

“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,” commented Dr. Caldwell in the company’s press release.

Dr. Caldwell, who is attending physician at Auckland City Hospital in Auckland, New Zealand, further stated, “The platform is designed to improve catheter deliverability offering the advantage of greater simplicity for the operating physician to efficiently perform thrombectomy for patients.”

The prospective, multicenter, single-arm SUMMIT NZ trial 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 (0.088 and 0.070 inch ID) to the M1. The trial using the 088 aspiration catheter technology for intracranial thrombectomy offers an encouraging signal that super-bore aspiration catheters may increase first pass reperfusion (mTICI ≥ 2b), stated the company.

Route 92 Medical’s HiPoint catheters, Tenzing catheters, and Base Camp sheath system have received FDA 510(k) clearance for neurovascular access, advised the company.