Record Shattered! Revolutionary Stroke Device Promises "One-and-Done" Clot Removal in Stroke Treatment

Route 92 Medical's HiPoint™ System shattered records, achieving the highest first-pass clot removal rate ever documented in a major stroke trial (SUMMIT MAX).
Unveiled at the prestigious European Stroke Organisation Conference (ESOC) 2025 in Helsinki, the revolutionary .088” super-bore catheter system has secured FDA clearance, heralding a new era in stroke intervention^{1, 6, 8}.
Experts acclaim this "one-and-done" technology as a game-changer, promising faster brain reperfusion and profoundly better outcomes for stroke patients where "time equals brain"⁶.

HELSINKI, Finland – A seismic wave of innovation in the fight against stroke surged through the European Stroke Organisation Conference (ESOC) 2025 today^{1, 6}. Route 92 Medical, Inc. electrified the global medical community with the announcement that its HiPoint™ Reperfusion System has not only received pivotal FDA 510(k) clearance but has also demonstrated the highest first-pass effect (FPE) ever reported in a randomized endovascular stroke thrombectomy study, the SUMMIT MAX trial^{6, 8}. This breakthrough promises to revolutionize how doctors combat acute ischemic stroke, where every second is critical to saving brain tissue.

The SUMMIT MAX trial data, presented at ESOC—a premier global forum for stroke research advancements held in Finland, a nation with a rich history in stroke innovation^{1, 3, 4, 5, 7}—showcased the undeniable superiority of the HiPoint™ System. Its super-bore .088” HiPoint 88 Aspiration Catheter, a first of its kind to receive clearance for direct aspiration in the neurovasculature, decisively outperformed conventional catheters, achieving unprecedented success in removing devastating stroke-causing clots on the very first attempt⁶.

"Time equals brain," a stark reminder from Dr. Thanh N. Nguyen, co-National Principal Investigator of the trial, underscores the urgency this system addresses^{6, 8}. The HiPoint™ System, with its streamlined Monopoint™ approach, is engineered for speed, simplicity, and overwhelming efficacy, empowering clinicians to restore blood flow faster and more completely. Dr. Guilherme Dabus hailed its potential as a "'one-and-done' workhorse product," capable of enabling more stroke patients to make fuller recoveries⁶.

This landmark achievement, born from a mission to "completely re-imagine neurovascular intervention," positions Route 92 Medical at the vanguard of stroke care. As trial data suggests even greater efficacy with increased experience, the widespread adoption of this U.S.-cleared system could dramatically improve the landscape for the nearly 800,000 Americans affected by stroke annually.

To learn more, visit www.r92m.com.

Record Shattered! Revolutionary Stroke Device Promises "One-and-Done" Clot Removal in Stroke Treatment

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