Route 92 HiPoint 88 Reperfusion System Cleared by FDA

May 21, 2025—Route 92 Medical, Inc. announced FDA 510(k) clearance (product code: NRY) for the company’s HiPoint reperfusion system, which includes the HiPoint 88 reperfusion system with the Tenzing 8 delivery catheter and featuring the Monopoint approach.

Additionally, the company announced results from its pivotal SUMMIT MAX randomized controlled trial. The endovascular stroke thrombectomy study compared the efficacy and safety of the company’s HiPoint reperfusion system, including the super-bore 0.088-inch HiPoint 88 aspiration catheter, to a conventional 0.074-inch catheter.

In February 2022, the company announced commencement of enrollment in the study to provide clinical evidence to support the application for FDA clearance.

The SUMMIT MAX data were presented at the 11th European Stroke Organization Conference held May 21-23 in Helsinki, Finland.

According to the company, SUMMIT MAX was conducted at 31 centers and enrolled 250 patients, and the analysis group included 166 patients. The findings demonstrated the superiority of the HiPoint system compared to the 0.074-inch aspiration catheter in achieving the primary efficacy endpoint of revascularization without use of any adjunctive therapy. Because the goal was to compare use of the aspiration catheters, any use of another NRY-labeled stroke device (such as a stent retriever) to complete the case was considered a failure in both arms of the trial, reported the company.

Key primary study findings included successful delivery of the HiPoint device to the stroke-causing occlusion in 89% of cases, significantly higher revascularization rates in the HiPoint arm compared to the control arm, and no significant difference between the two study groups for the primary safety endpoint of symptomatic intracranial hemorrhage.

The coprincipal investigators of the SUMMIT MAX study are Thanh N. Nguyen, MD; Ajit Puri, MD; and Guilherme Dabus, MD.

“The clinical community has long believed that an 0.088-inch super-bore aspiration catheter could improve stroke care by improving first-pass effect (FPE),” commented Dr. Nguyen in the Route 92 press release. “We require systems of devices capable of improving the quality of reperfusion, reducing procedure times, and simplifying the procedure because time equals brain. Having an FDA-cleared solution backed by the robust data we saw in the SUMMIT MAX clinical trial will go a long way toward advancing stroke care in the United States.”

Dr. Puri added, “These results were similar to the results of the multicenter study Dr. Dabus and I conducted in 2022 whose results were published in the Journal of Neurointerventional Surgery (2023;15:664-668). 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.”