Route 92 Medical announced positive results from its SUMMIT MAX trial of the HiPoint Reperfusion System, including the super-bore .088” HiPoint 88 Aspiration Catheter for stroke treatment. The system received 510(k) clearance, making it the first super-bore direct aspiration system cleared for stroke treatment. The SUMMIT MAX trial showed the HiPoint system to be superior to conventional aspiration catheters in achieving revascularization.
This clearance is a major advancement in stroke care. The larger bore catheter allows for more efficient clot removal, potentially leading to faster and more complete reperfusion of the brain. This is crucial in stroke treatment as time is of the essence in minimizing brain damage and improving patient outcomes. The availability of a cleared super-bore aspiration catheter is a significant step towards enhancing stroke intervention and improving patient recovery.
The SUMMIT MAX trial, involving 166 participants, demonstrated an 89% success rate in delivering the HiPoint 88 Aspiration Catheter to the occlusion site. The HiPoint system achieved significantly higher revascularization rates compared to the control group, without a significant difference in symptomatic intracranial hemorrhage rates. A sub-study of the three highest-enrolling centers showed even more promising results with 96% delivery success to the M1 segment (the most common stroke location) and a 96% revascularization rate. These centers also reported an 84% first-pass effect (FPE) with the HiPoint 88 system, compared to 53% in the control arm, and no instances of symptomatic intracranial hemorrhage. High FPE rates are correlated with better patient outcomes, faster procedure times, and less need for additional devices.
The clearance of the HiPoint Reperfusion System and the positive SUMMIT MAX trial results suggest a significant advancement in stroke treatment. Wider adoption of this technology could translate to shorter procedure times, higher FPE rates, and ultimately, improved patient outcomes and reduced long-term disability following a stroke. This development may shift the standard of care in stroke intervention, offering a more effective and efficient method of clot removal and reperfusion.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
