YOKNEAM, Israel & MIAMI--(BUSINESS WIRE)--Rapid Medical, a leading developer of advanced neurovascular devices, announced today the enrollment of the first patient in the DISTALS Study. The trial is the first-ever FDA investigational device exemption (IDE) trial to examine the safety and effectiveness of mechanical thrombectomy in distal stroke.
“Enrolling the first patient in this landmark study is an important milestone for patients,” says Dr. Hannes Nordmeyer, Neuroradiology Department head at radprax Neurocenter in Solingen, Germany. “We know from large vessel ischemic stroke that restoring blood flow to the brain as quickly as possible provides greatly improved outcomes. Now that we have the technology to reach distal strokes with TIGERTRIEVER 13, we must understand the patient benefit in quickly opening smaller blood vessels as well.”
This new frontier for ischemic stroke is pioneered by Rapid Medical’s TIGERTRIEVER™13, the smallest and only adjustable thrombectomy device available. With TIGERTRIEVER 13’s adjustability and complete visibility, physicians remotely control contact with the vessel and clot. This way, each step of the procedure can be optimized.
Less than 10% of ischemic stroke patients receive mechanical thrombectomy, a well-proven treatment that significantly improves patient outcomes. With Rapid Medical's TIGERTRIEVER 13, the DISTALS Study aims to extend these benefits to an additional 25 – 40% of stroke patients. It focuses on outlying brain territories, such as M3 blood vessels, and allows intervention within 24 hours from symptoms onset.
The news follows an international Investigator’s meeting held with trial site principal investigators in New York City– including Drs. Jeffrey Saver at UCLA in Los Angeles, CA; Rishi Gupta at Wellstar Health System in Marietta, GA; David Fiorella at Stony Brook University Medical Center in Stony Brook, NY; and Professor René Chapot at Alfried Krupp Krankenhaus in Essen, Germany. At the event, the world’s leading experts discussed challenges in treating this patient population and optimizing the procedure.
“We are thrilled to have such a powerful team of physician contributors to help advance the field,” elates Dr. Walid Haddad, Chief Clinical Officer at Rapid Medical. “We are gaining deeper insights into stroke and how the device’s novel design can be critical in safely treating these delicate areas of the brain.”
In addition to the first patient enrolled by Dr. Hannes Nordmeyer in Germany, Dr. Elad Levy at University at Buffalo Neurosurgery in NY just enrolled the first US patient.
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.