San Mateo, California-based Route 92’s HiPoint system includes the HiPoint 88 system powered by Tenzing 8, featuring the Monopoint approach. The company says it became the first neurovascular intervention company to win clearance for direct aspiration of a stroke-causing thrombus with a super-bore .088” catheter in the neurovasculature.
HiPoint 88 features an aspiration catheter (its 88 and 70 aspiration catheters), Tenzing 8 delivery catheter and Base Camp 2.0 sheath. It has a Monopoint approach, advancing from a single point of control. Tenzing-powered delivery enables atraumatic navigation through tortuous anatomy. It offers clinicians the flexibility to deliver vessel-matched, super-bore catheters to the M1. This also enables the rapid and efficient removal of large vessel occlusions — the cause of many acute ischemic strokes.
The company also announced positive results from a clinical trial evaluating its HiPoint reperfusion system.
The SUMMIT MAX trial compares the efficacy and safety of HiPoint (with the super-bore .088” HiPoint 88 aspiration catheter) to a conventional 0.74″ catheter. Investigators presented findings at the European Stroke Organisation Conference (ESOC) in Helsinki, Finland.
A look at the Route 92 Medical study results
SUMMIT MAX demonstrated the superiority of HiPoint compared to a conventional catheter, Route 92 said, achieving the primary endpoint of revascularization.
The study included 166 participants. Clinicians successfully delivered HiPoint 88 to the stroke-causing occlusion in 89% of cases. Route 92 said its treatment arm showed significantly higher revascularization rates compared to the control. Investigators saw no significant difference for the primary safety endpoint of symptomatic intracranial hemorrhage (sICH).
Additionally, a sub-study analysis highlighted how centers with more experience with Route 92 products achieved even better results. Out of 57 participants at three centers, clinicians successfully delivered HiPoint 88 to the target M1 segment of the middle cerebral artery in 96% of cases. That led to a 96% revascularization rate. This sub-study also saw no cases of sICH in the Route 92 arm. Patients in that group also required significantly less (4% vs. 53%) use of adjunctive devices (like stent retrievers) to achieve revascularization.
“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. Our data show the power in this approach,” said Dr. Tony Chou, founder and CEO at Route 92 Medical. “We are grateful to the investigators, patients and patient families who participated in this trial and shared our faith in the potential of a comprehensive portfolio of vessel-size-matched catheters to improve acute ischemic stroke thrombectomy procedures and ultimately patient outcomes.”
