Rapid Medical Reports Positive DISTALS Trial Results for TIGERTRIEVER 13 in Distal Stroke Treatment
Rapid Medical, a medical technology company focused on advanced stroke treatment solutions, has announced full results from the DISTALS randomized clinical trial during the 11th European Stroke Organisation Conference 2026 (ESOC). The study findings demonstrated that the company’s TIGERTRIEVER™ 13 device successfully restored blood flow in patients suffering from distal and medium vessel occlusion (DMVO) stroke while maintaining a strong safety profile and showing encouraging signs of improved clinical recovery.
The results represent an important development in the evolving field of stroke intervention, particularly for patients with distal and medium vessel occlusions, an area where treatment options have historically been limited. According to Rapid Medical, the trial findings build upon previously reported data showing that the TIGERTRIEVER 13 device achieved approximately a threefold improvement in restoring blood flow compared with medical management alone, with statistical significance reported at p<0.0001.
Importantly, investigators also reported that no cases of symptomatic intracranial hemorrhage, or serious brain bleeding, were observed among patients treated with the device during the study.
Stroke remains one of the leading causes of death and long-term disability worldwide. Ischemic strokes, which occur when blood flow to the brain is blocked by a clot, account for the majority of stroke cases. While major advances have been made in recent years with mechanical thrombectomy procedures for large vessel occlusions, treatment approaches for distal and medium vessel occlusions have remained less clearly defined.
Distal and medium vessel occlusions are estimated to account for nearly half of all ischemic strokes. However, these smaller vessels are more difficult to access and treat because of their delicate anatomy and narrow diameter. Many currently available thrombectomy systems were originally developed for larger vessels and may not be ideally suited for navigating or safely operating in distal cerebral arteries.
Rapid Medical designed TIGERTRIEVER 13 specifically to address these procedural challenges. According to the company, the device is the only thrombectomy system engineered to actively adjust to vessel anatomy during treatment, allowing physicians to adapt the device to the size and shape of smaller blood vessels encountered in distal stroke procedures.
The DISTALS trial was specifically developed to evaluate both the device and procedural strategy for this underserved stroke population. Investigators emphasized that the study design focused on distal stroke intervention rather than adapting treatment methods originally intended for larger vessel occlusions.
Jeffrey L. Saver, principal investigator of the DISTALS study and a stroke specialist at UCLA, stated that the trial results demonstrate the ability to safely restore blood flow in distal stroke patients while also suggesting the potential for meaningful clinical improvement.
According to Saver, one of the most important aspects of the study was that both the device and the trial methodology were purpose-built for distal stroke treatment. He noted that by using a device specifically designed for smaller cerebral vessels and by evaluating outcomes at the brain tissue level, the study established a stronger foundation for translating successful reperfusion into improved patient recovery.
Clinical outcome data collected at three months after treatment showed several encouraging trends favoring the TIGERTRIEVER 13 device. Patients treated with the device achieved higher rates of little or no disability, as measured by modified Rankin Scale scores of 0–1, compared with patients receiving medical therapy alone.
The modified Rankin Scale, commonly referred to as mRS, is a widely used measurement system for assessing disability and functional independence after stroke. Scores of 0 or 1 typically indicate minimal or no significant disability.
In the DISTALS trial, 41.2% of patients treated with TIGERTRIEVER 13 achieved mRS 0–1 outcomes compared with 38.2% in the control group treated with standard medical management alone.
Investigators also observed particularly meaningful improvements among patients who entered the trial with moderate to severe disability. Among patients with baseline modified Rankin Scale scores between 2 and 5, approximately 69% of patients treated with the device improved by at least one disability level, compared with 56% of patients in the control group.
The study additionally identified stronger outcomes among patients treated under general anesthesia. Researchers indicated that procedural approach and treatment technique may play an important role alongside device technology in optimizing outcomes for distal vessel thrombectomy procedures.
David Fiorella, principal investigator of the DISTALS study and physician at Stony Brook University Hospital, stated that the findings demonstrate meaningful recovery potential in a patient population where therapeutic options have historically been limited.
According to Fiorella, nearly three-quarters of patients with more severe baseline disability experienced clinical improvement following treatment with the device. He also emphasized that outcomes appeared even stronger when procedures were performed under general anesthesia, suggesting that procedural strategy and technical execution are critical components of successful distal stroke intervention.
In addition to improvements in disability scores, the trial also evaluated patient quality of life outcomes. Rapid Medical reported that more than twice as many patients treated with TIGERTRIEVER 13 experienced a full return to normal quality of life compared with patients managed with medical therapy alone.
Safety outcomes remained another major focus of the study because intervention in small cerebral vessels carries potential risks related to vessel injury and bleeding. According to the trial results, the safety profile remained favorable, with no symptomatic brain hemorrhages reported among device-treated patients. Ninety-day survival rates were also reported to be similar between the treatment and control groups.
The findings presented at ESOC 2026 contribute to the growing body of evidence supporting the expansion of mechanical thrombectomy into smaller vessel territories. Over the past decade, thrombectomy has become a standard treatment for large vessel ischemic stroke following multiple landmark clinical trials demonstrating substantial benefits in functional recovery.
However, the role of thrombectomy for distal and medium vessel occlusions has remained under active investigation because these strokes often involve more technically challenging anatomy and smaller clot burdens. Many stroke specialists have argued that dedicated devices and optimized procedural techniques are necessary before broader adoption can occur in this patient population.
Rapid Medical believes the TIGERTRIEVER 13 system may help address these unmet needs through its adjustable design and vessel-specific engineering. The company stated that the device’s ability to conform to vessel anatomy supports safer clot retrieval and more effective reperfusion in distal cerebral arteries.
The DISTALS trial results may also have important regulatory implications. Rapid Medical announced plans to pursue clearance from the U.S. Food and Drug Administration based on the clinical findings generated during the study.
If regulatory clearance is obtained, the device could potentially expand treatment options for a substantial number of stroke patients who currently have limited interventional therapies available.
The presentation of the data at the European Stroke Organisation Conference also underscores growing international interest in advancing treatment standards for distal vessel stroke. As stroke intervention technologies continue evolving, researchers and clinicians are increasingly focused on improving access to treatment for broader patient populations while minimizing procedural risk.
The DISTALS trial represents another step in that direction by specifically targeting an underserved group of ischemic stroke patients with a device tailored to their anatomical and clinical needs.
With positive reperfusion outcomes, encouraging functional recovery signals, and a strong safety profile, Rapid Medical’s TIGERTRIEVER 13 may help shape the next phase of innovation in stroke thrombectomy and distal vessel intervention.
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.
