Rapid Medical™’s DISTALS Trial Overwhelmingly Positive, Demonstrating Superior Reperfusion with TIGERTRIEVER™ 13 in Medium Vessel Stroke

TIGERTRIEVER 13 is the first device shown to meet safety and effectiveness endpoints for restoring blood flow in smaller but critical areas of the brain, accounting for almost 50% of all ischemic strokes

NEW ORLEANS & YOKNEAM, Israel–(BUSINESS WIRE)–#DISTALS—Rapid Medical, a leading developer of active endovascular devices, today announced late-breaking results from the DISTALS multicenter, randomized controlled trial showing that TIGERTRIEVER 13 achieved superior brain tissue reperfusion with an excellent safety profile when compared with medical management in medium vessel occlusion (MVO) stroke. The findings were presented in the main closing session at the 2026 International Stroke Conference (ISC).

Top-line results showed that the TIGERTRIEVER 13 arm demonstrated 3x 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 – 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,” said Jeffrey L. Saver, MD, Principal Investigator of DISTALS. “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,” said Rishi Gupta, MD, Principal Investigator of DISTALS. “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 FDA clearance based on these results, with full study findings to be presented at a future academic conference.

About Rapid Medical
Rapid Medical expands what’s possible in neurovascular treatment by pioneering advanced interventional devices that treat ischemic and hemorrhagic stroke. Utilizing 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. More information is available at www.rapid-medical.com.

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.

Contacts

Ronen Eckhouse
+972-72-2503331
[email protected]