Rapid Medical’s Tigertriever 13 Receives IDE Approval for DISTALS Trial of Stroke Treatment

November 3, 2021—Rapid Medical announced FDA investigational device exemption (IDE) approval for a trial to expand interventional stroke treatment to distal regions of the brain.

According to the company, the DISTALS study is a pivotal, international, multicenter, randomized controlled trial to evaluate the safety and effectiveness of distal thrombectomy using Rapid Medical’s Tigertriever 13 device.

The company noted that < 10% of ischemic stroke patients currently receive mechanical thrombectomy. Whereas, the Tigertriever 13 has already been used to treat approximately 1,500 patients in Europe and the Middle East, the DISTALS study aims to extend the benefit of this treatment to an additional 25% to 40% of stroke patients. It focuses on far territories in the brain, such as M3 blood vessels, and allows intervention within 24 hours from symptoms onset.

“We’re especially pleased to receive unprecedented FDA IDE approval for a study with DISTALs focus,” commented Principal Investigator Jeffrey Saver, MD, in the company’s press release. “With the ever-growing benefits of mechanical thrombectomy, we hope to offer better recoveries to a much broader patient population. Rapid Medical has been at the forefront of enabling that progress.” Dr. Saver is Professor of Neurology and Director of the Comprehensive Stroke and Vascular Neurology Program at UCLA in Los Angeles, California.

David Fiorella, co-coordinating investigator of the study, added, “The DISTALS trial is critical for the field of interventional stroke therapy. It potentially allows us to offer thrombectomy to an additional large group of stroke patients who may benefit substantially.” Dr. Fiorella is Director of the Cerebrovascular Center at Stony Brook University Medical Center in Stony Brook, New York.

The study’s leading investigators also include René Chapot, MD, Professor and Department Head of Neuroradiology and Radiology at Alfried Krupp Krankenhaus in Essen, Germany, and Rishi Gupta, MD, and Director of Neurocritical Care at Wellstar Health System in Marietta, Georgia.