Rapid Medical Commences DISTALS IDE Trial of Tigertriever 13 Thrombectomy Device in Distal Stroke

June 2, 2022—Rapid Medical, an Israel-based developer of neurovascular devices, announced the enrollment of the first patient in the DISTALS study. The FDA investigational device exemption (IDE) trial will examine the safety and effectiveness of mechanical thrombectomy using the company’s Tigertriever 13 adjustable thrombectomy device in distal stroke.

The first patient in the trial was enrolled by Hannes Nordmeyer, MD, Neuroradiology Department head at Radprax Neurocenter in Solingen, Germany. Elad Levy, MD, with University at Buffalo Neurosurgery in Buffalo, New York enrolled the first patient in the United States.

“Enrolling the first patient in this landmark study is an important milestone for patients,” commented Dr. Nordmeyer in the company’s press release. “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.”

The company noted than < 10% of ischemic stroke patients receive mechanical thrombectomy. The DISTALS study aims to extend the benefits of mechanical therapy to an additional 25% to 40% of stroke patients using the Rapid Medical Tigertriever 13. Treatment with the device focuses on outlying brain territories, such as M3 blood vessels, and allows intervention within 24 hours from symptoms onset, stated Rapid Medical.