Route 92 Medical recently announced the publication of an investigator-initiated, multicentre SLIC (Super large-bore ingestion of clot) study of its proprietary Monopoint operating platform, showing 82% first-pass efficacy, according to a press release.
Results from 33 consecutive patients also demonstrated 100% success in reaching the intracranial occlusion with the company’s HiPoint 88 (0.088-inch inner diameter [ID]) super-bore catheter, a groin-to-recanalisation 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 have been published online in the Journal of NeuroInterventional Surgery (JNIS).
“This initial experience across three experienced, high-volume neurointerventional centres using the SLIC technique for treatment of acute ischaemic 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 Ajit Puri (University of Massachusetts Medical Center, Worchester, USA), 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.”
The SLIC study, which was conducted without input from Route 92, was a retrospective review of three comprehensive stroke centre 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 company’s 8Fr Base Camp sheath, HiPoint 88 super-bore catheter and Tenzing delivery catheter.
As per the Route 92 press release, the study is the largest reported series using 088 aspiration catheter technology for intracranial thrombectomy.
The use of the HiPoint catheter for stroke treatment is currently being evaluated in the USA under a US Food and Drug Administration (FDA)-approved investigational device exemption (IDE) study named SUMMIT MAX—but, according to the company, these recent JNIS data are separate from SUMMIT MAX.
“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,” said Tony Chou, founder and CEO of Route 92.
“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 randomised 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 ischaemic stroke.”