Route 92 Medical has announced the publication of initial results from the SUMMIT NZ clinical trial—a single-arm, multicentre, prospective trial evaluating its proprietary Monopoint operating platform.
Results from the first 45 patients demonstrated that the Monopoint platform yielded an 80% first-pass effect with primary use of the HiPoint 88 (0.088-inch internal diameter [ID]) catheter, which is 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, as per a company press release. These results have been published online in the 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, signalling clear potential for improved patient outcomes given the importance of clearing thrombus to save time and save brain,” said James Caldwell (Auckland City Hospital, Auckland, New Zealand), 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 has enrolled patients across New Zealand to evaluate the safety and clinical efficacy of the novel Monopoint operating platform in delivering the super-bore and large-bore HiPoint aspiration catheters (0.088-inch ID and 0.070-inch ID) to the M1. The release claims that this 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 (modified thrombolysis in cerebral infarction [mTICI] ≥2b).
“An increase in first-pass effect is highly correlated with superior outcomes and reduction in disability. 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, consultant medical director of Route 92. “These initial SUMMIT NZ results establish a strong foundation for building level one evidence of patient benefit, and we look forward to completing Route 92 Medical’s randomised clinical trial SUMMIT MAX, comparing the Monopoint operating platform against the current largest bore catheter system on the market.”
According to the release, Route 92’s HiPoint catheters, Tenzing catheters and Base Camp sheath system have all previously received US Food and Drug Administration (FDA) 510(k) clearance for neurovascular access too.