Route 92 Medical today announced results from a real-world study evaluating reperfusion outcomes with its HiPoint system.
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 received FDA clearance in May, making it the first and only FDA-cleared 0.088″ reperfusion catheter system for direct aspiration of large vessel occlusions in patients experiencing an acute ischemic stroke.
The retrospective, multicenter study collected outcomes data from 193 consecutive patients treated with HiPoint. These patients weren’t part of the SUMMIT MAX trial. The study had primary endpoints of first-pass effect of mTICI 2c/3 (a measure of clot removal) and first-pass effect, defined as mTICI 2b/2c/3 reperfusion on the first aspiration pass, with secondary endpoints including rate of successful aspiration catheter delivery, number of passes for final reperfusion, and conversion to other systems or devices.
Clinicians successfully delivered the HiPoint system to the stroke-causing occlusion in 96.2% of cases. Route 92 reports the achievement of the primary endpoint of first-pass effect mTICI 2c/3 in 57.5% of cases. The primary endpoint of first-pass effect of mTICI 2b/2c/3 was achieved in 68.4% of cases
Route 92 also introduced SUMMIT RISE, a prospective, 500-patient study to evaluate its portfolio across a wide range of cases.
“We believe the evidence base supporting the use of Route 92 Medical’s technologies in neurovascular interventional procedures continues to grow. With each new study, there is additional support for the use of our Tenzing-based intervention approach, showing its ability to safely and effectively reach and aspirate clots, while improving first-pass effect relative to other catheter products,” said Dr. Tony Chou founder and CEO at Route 92 Medical. “With SUMMIT RISE, we plan to evaluate patient outcomes over time, across devices and sites, and to provide additional data showing that our tools achieve clinical objectives and help give patients the best opportunity to recover from acute ischemic stroke.”
