Rapid Medical is sharing positive results from the DISTALS multicenter, controlled trial showing that its TIGERTRIEVER 13 achieved superior brain tissue reperfusion with an excellent safety profile when compared with medical management in medium vessel occlusion (MVO) stroke.

Top-line results from the multicenter study showed the TIGERTRIEVER 13 arm demonstrated three-fold more successful reperfusion without symptomatic intracranial hemorrhage (sICH) compared to medical management–86.3% vs 27.7% (p < 0.001). Notably, zero sICH events were reported in the randomized treatment arm treated with TIGERTRIEVER 13. By comparison, sICH rates reported with intravenous thrombolysis alone are higher, ranging from 2% to 6% in contemporary trials.^1,2,3

“These results highlight what is possible when both the device and the trial are designed specifically for distal stroke,” DISTALS principal investigator Jeffrey L. Saver, M.D., stated. “DISTALS was purpose-built for distal stroke, pairing a device engineered for small, fragile vessels with a tissue-based endpoint designed to measure meaningful brain reperfusion.”

Until today, no thrombectomy device has demonstrated safe flow restoration in randomized trials for MVO stroke, leaving care for this underserved stroke population—accounting for close to 50% of all ischemic strokes—uncertain. DISTALS evaluated a distal-specific device, TIGERTRIEVER 13, the only thrombectomy system designed to actively adjust to the vessel anatomy, and also assessed treatment success using CT perfusion (CTP), which measures blood flow restoration to threatened brain tissue rather than simply confirming vessel opening. Together, the distal-first device design and tissue-level trial endpoints provide a more appropriate and clinically meaningful approach to evaluating—and advancing—care for distal stroke.

“Distal thrombectomy demands dedicated device engineering,” DISTAL principal investigator Rishi Gupta, M.D., said. “Most thrombectomy complications occur during retrieval, when excess tension can injure delicate vessels. TIGERTRIEVER 13 actively reduces force before and during retrieval, adapting to distal anatomy to minimize vessel stress. The DISTALS results reinforce why distal-first technology matters for patients.”

The company plans to pursue U.S. Food and Drug Administration clearance based on these results, with full study findings to be presented at a future academic conference.

Rapid Medical is developing advanced interventional devices that treat ischemic and hemorrhagic stroke. Using proprietary manufacturing techniques, Rapid Medical’s products are remotely adjustable and fully visible. This enables physicians to respond in real-time to the anatomy and tailor their approach to each patient for better procedural outcomes. Product families include TIGERTRIEVER, COMANECI, and DRIVEWIRE. Not all products are available in all geographies.

References
¹ Goyal M, Ospel JM, Ganesh A, et al. Endovascular Treatment of Stroke Due to Medium-Vessel Occlusion. N Engl J Med. 2025;392(14):1385-1395. doi:10.1056/NEJMoa2411668
² Psychogios M, Brehm A, Ribo M, et al. Endovascular Treatment for Stroke Due to Occlusion of Medium or Distal Vessels. N Engl J Med. 2025;392(14):1374-1384. doi:10.1056/NEJMoa2408954
³ DISCOUNT Trial. Presented at the International Stroke Conference (ISC); February 2025; Los Angeles, CA.