Route 92 Medical has announced groundbreaking results from its SUMMIT MAX clinical trial, demonstrating that its HiPoint 88 Reperfusion System achieved the highest first pass effect (FPE) ever reported in a randomized endovascular stroke thrombectomy study. The company simultaneously announced FDA 510(k) clearance for the system, making it the first stroke treatment device to receive a super-bore direct aspiration label.
The 250-patient, 31-center randomized controlled trial compared the efficacy and safety of the HiPoint Reperfusion System featuring the super-bore .088" HiPoint 88 Aspiration Catheter against a conventional .074" catheter. Results were presented at the European Stroke Organisation Conference (ESOC) in Helsinki, Finland.
Unprecedented First Pass Effect Results
The trial demonstrated superior revascularization rates with the HiPoint system compared to conventional catheters. Among the 166 patients in the analysis group, clinicians successfully delivered the HiPoint 88 Aspiration Catheter to the stroke-causing occlusion in 89% of cases.
Most notably, data from the three highest-enrolling centers showed remarkable outcomes:
- 96% successful delivery to M1 occlusions in the middle cerebral artery
- 84% first pass effect (FPE) for mTICI ≥2b versus 53% with conventional catheters (p=0.02)
- 68% FPE for mTICI ≥2c versus 30% with conventional catheters (p=0.007)
- No symptomatic intracranial hemorrhage in the Route 92 Medical arm
- Significantly reduced need for adjunctive devices (4% versus 53%, p<0.0001)
"The importance of improving FPE is critical and has been evolving over the past decade," said Dr. Guilherme Dabus, Co-Director of Interventional Neuroradiology at Miami Neuroscience Institute and study co-Principal Investigator. "Patients experience better outcomes when we can remove a clot and get blood flowing into all parts of the brain more quickly, in one pass."
System Design and Technological Innovation
The HiPoint Reperfusion System comprises the HiPoint 88 Aspiration Catheter, Tenzing 8 Delivery Catheter, HiPoint 70, Tenzing 7 Delivery Catheter, and Base Camp 2.0 Sheath. It features the Monopoint approach, a streamlined telescoping design that advances from a single point of control.
"Route 92 Medical was founded to completely re-imagine neurovascular intervention. We believe that simpler set-ups designed to be used as complete systems will radically transform stroke treatment," said Tony Chou, M.D., founder and chief executive officer at Route 92 Medical.
The system's Tenzing-powered delivery allows for atraumatic navigation through tortuous anatomy, offering clinicians the flexibility to deliver vessel-matched, super-bore catheters to the M1 segment while enabling rapid and efficient removal of large vessel occlusions.
Clinical Implications for Stroke Treatment
Dr. Thanh N. Nguyen, Professor of Neurology, Neurosurgery and Radiology at Boston University School of Medicine and co-National Principal Investigator, emphasized the significance of the findings: "The clinical community has long believed that an 0.088-inch super-bore aspiration catheter could improve stroke care by improving first pass effect. We require systems of devices capable of improving the quality of reperfusion, reducing procedure times and simplifying the procedure because time equals brain."
The study results validate earlier findings published in the Journal of Neurointerventional Surgery, according to Dr. Ajit S. Puri, Professor at University of Massachusetts Medical Center and study co-Principal Investigator. "The high rates of FPE seen in this trial validate our similar findings and show the power of vessel-size-matched aspiration catheters to drive procedural success."
Addressing a Major Public Health Challenge
Stroke remains a leading cause of long-term disability and death in the United States. According to the CDC, approximately 795,000 Americans suffer strokes annually, with 87% being ischemic strokes where blood flow to the brain is blocked. Despite advances in treatment, stroke remains the fifth leading cause of death in the U.S., responsible for approximately 165,000 deaths each year.
The FDA clearance of the HiPoint Reperfusion System represents a significant advancement in stroke care. As the first neurovascular intervention company to receive clearance for direct aspiration of a stroke-causing thrombus with a super-bore .088" catheter, Route 92 Medical is positioned to potentially transform the standard of care for endovascular stroke thrombectomy.
The SUMMIT MAX trial results suggest that centers with more experience using the Route 92 Medical products achieved even more impressive outcomes, indicating the potential for improved clinical results as these products become more widely adopted in clinical practice.
Dr. Dabus concluded, "We believe having on-label tools with improved FPE rates will enable many more stroke patients to make more complete recoveries."
