Route 92 Medical announced its HiPoint Reperfusion System, including the .088in HiPoint 88 aspiration catheter, has shown positive outcomes in the SUMMIT MAX trial compared to a conventional .074in catheter for endovascular stroke thrombectomy.
The randomised, controlled trial assessed the safety and efficacy of the system.
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Its analysis group included 166 subjects and highlighted the HiPoint reperfusion system’s higher revascularisation rates versus the control arm.
The catheter reached the occlusion in 89% of cases. Moreover, there was no significant difference observed in the primary safety endpoint of symptomatic intracranial haemorrhage between the two groups.
The HiPoint system comprises several components, including the HiPoint 88 aspiration catheter and the Tenzing 8 delivery catheter.
It features the Monopoint approach, a telescoping design that progresses from one point of control.
The Tenzing-powered delivery system enables atraumatic navigation through tortuous anatomy and assists clinicians in delivering super-bore catheters, which are vessel-matched, to M1.
It also allows for the quick removal of large vessel occlusions, a common cause of acute ischemic strokes.
Additionally, the company has received 510(k) clearance from the US Food and Drug Administration (FDA) for the system, including the HiPoint 88 Reperfusion System powered by Tenzing 8.
Route 92 Medical CEO and founder Tony Chou said: “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.
“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.”
In September 2024, the company secured $50m in a Series F financing round to support the global commercialisation of its FreeClimb and Tenzing devices.
