Rapid Medical’s TIGERTRIEVER 13 Demonstrates Promising 90-Day Outcomes

Rapid Medical is sharing full results from the DISTALS randomized clinical trial that indicate its TIGERTRIEVER 13 device can safely restore blood flow to the brain and may improve clinical outcomes in patients with distal and medium vessel occlusion (DMVO) stroke. The findings build on earlier results showing a threefold improvement in restoring blood flow compared with medical management alone (p<0.0001), with no cases of serious brain bleeding observed in the treatment group.

“These results show we can now safely restore blood flow and suggest this will make a meaningful difference for the right patients,” said Jeffrey L. Saver, M.D., the trial’s principal investigator. “What’s important is that both the device and the trial were designed specifically for distal stroke. By using a device built for these small vessels and measuring outcomes at the brain tissue level, we have set the stage for translating flow restoration into better recovery.”

Clinical outcomes at three months show encouraging signals of benefit. Patients treated with the device demonstrated higher rates of little or no disability (modified Rankin Scale (mRS 0–1)) compared with medical therapy alone (41.2% vs. 38.2%), and meaningful recovery among those with moderate to severe strokes (mRS 2-5) at baseline, with 69% improving by at least one level of disability compared with 56% in the control. Additional benefits were observed in patients treated under general anesthesia.

More than twice as many patients treated with TIGERTRIEVER 13 reported a full return to normal quality of life. At the same time, safety remained strong, with no symptomatic brain bleeding and similar 90-day survival rates between groups.

“We’re seeing meaningful recovery in a patient population where treatment options have historically been limited,” stated David Fiorella, M.D., Ph.D., Stony Brook University Hospital, and DISTALS principal investigator. “Nearly three-quarters of more severely disabled patients improved, and outcomes were even stronger with general anesthesia. That tells us technique and approach matter just as much as the device itself when treating distal occlusions.”

Distal and medium vessel strokes account for nearly half of all strokes but have had limited treatment options. TIGERTRIEVER 13, reportedly the only thrombectomy system designed to actively adjust to the vessel anatomy, is built for these smaller vessels and supports safe reperfusion and improved outcomes. The company plans to pursue U.S. Food and Drug Administration clearance based on these results.

Rapid Medical is pioneering 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.