Rapid Medical announced today the enrolment of the first patient in the DISTALS study, which the company claims is the first-ever US Food and Drug Administration (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,” said Hannes Nordmeyer (Radprax Neurocenter, Solingen, Germany). “We know from large vessel ischaemic 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 [Rapid], we must understand the patient benefit in quickly opening smaller blood vessels as well.”
This new frontier for ischaemic stroke is pioneered by Rapid’s Tigertriever 13, the smallest and only adjustable thrombectomy device available, according to a press release. 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 optimised, the release adds.
Fewer than 10% of ischaemic stroke patients receive mechanical thrombectomy—a well-proven treatment that significantly improves patient outcomes—the release continues. With the Tigertriever 13, the multicentre, pivotal DISTALS study aims to extend these benefits to an additional 25–40% of stroke patients, focusing on outlying brain territories, such as M3 blood vessels, and allowing intervention within 24 hours from symptoms onset.
The news follows an international investigators’ meeting held with trial site principal investigators in New York City, USA—including Jeffrey Saver (UCLA, Los Angeles, USA), Rishi Gupta (Wellstar Health System, Marietta, USA), David Fiorella (Stony Brook University Medical Center, Stony Brook, USA) and René Chapot (Alfried Krupp Krankenhaus, Essen, Germany). At the event, the world’s leading experts discussed challenges in treating this patient population and optimising the procedure, according to the release.
“We are thrilled to have such a powerful team of physician contributors to help advance the field,” stated Walid Haddad, chief clinical officer at Rapid. “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 being enrolled by Nordmeyer in Germany, Rapid says that Elad Levy (University at Buffalo Neurosurgery, New York, USA) recently enrolled the first US patient at his centre as well.