YOKNEAM, Israel & MIAMI--(BUSINESS WIRE)--Rapid Medical, a leading developer of advanced neurovascular devices, today announced FDA investigational device exemption (IDE) approval for the first-ever trial to expand interventional stroke treatment to distal regions of the brain. The DISTALS Study is a pivotal, international, multi-center, randomized controlled trial (RCT) to evaluate the safety and effectiveness of distal thrombectomy. This new frontier for ischemic stroke has been created by Rapid Medical’s development of TIGERTRIEVER™ 13, the smallest thrombectomy device available.
“We're especially pleased to receive unprecedented FDA IDE approval for a study with DISTALs focus," elates Jeffrey Saver, MD, FAHA, Professor of Neurology and Director of the Comprehensive Stroke and Vascular Neurology Program at UCLA in Los Angeles, CA and principal investigator. "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."
Currently, less than 10% of ischemic stroke patients receive mechanical thrombectomy, a well-proven treatment that significantly improves patient outcomes. While Rapid Medical's TIGERTRIEVER 13 has already been used to treat nearly 1500 patients in Europe and the Middle East, the DISTALS Study aims to extend these benefits to an additional 25 – 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.
"The DISTALS trial is critical for the field of interventional stroke therapy,” says David Fiorella, MD, PhD and Director of the Cerebrovascular Center at Stony Brook University Medical Center in Stony Brook, NY and co-coordinating investigator. "It potentially allows us to offer thrombectomy to an additional large group of stroke patients who may benefit substantially.”
Ronen Eckhouse, Co-Founder and CEO of Rapid Medical, says the company plans to start the study in Q421 or early Q122. "We announced this news on World Stroke Day to emphasize its significance. Effective treatment of distal stroke represents a leap forward–to diminishing the devastating effects of stroke."
The 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, GA.
About Rapid Medical
Rapid Medical develops the premier, responsive interventional devices for neurovascular diseases such as ischemic and hemorrhagic stroke. Utilizing novel manufacturing techniques, Rapid Medical’s products are remotely adjustable and fully visible. This enables physicians to respond in real-time to the intravascular environment and have greater control over procedural outcomes. TIGERTRIEVER™17 and 21, COMANECI™ and COLUMBUS™/DRIVEWIRE are CE marked and FDA cleared. TIGERTRIEVER™13 and XL are also CE marked. More information is available at www.rapid-medical.com.