FDA OKs trial to test stroke treatment in distal brain regions

The FDA has granted investigational device exemption approval to Rapid Medical for a trial to expand stroke treatment to distal brain regions, according to a press release.

The DISTALS study, a randomized controlled trial seeking to examine the safety and effectiveness of distal thrombectomy, will involve Rapid Medical’s Tigertriever 13, the smallest thrombectomy device available.

“We're especially pleased to receive unprecedented FDA IDE approval for a study with DISTALS’ focus," principal investigator Jeffrey Saver, MD, FAHA, professor of neurology and director of the Comprehensive Stroke and Vascular Neurology Program at UCLA, said in the release. "With the ever-growing benefits of mechanical thrombectomy, we hope to offer better recoveries to a much broader patient population.”

At present, less than 10% of patients who had ischemic stroke received mechanical thrombectomy, which has been shown to significantly improve outcomes, according to the release. Tigertriever 13 has been used in approximately 1,500 patients in Europe and the Middle East. With data from the DISTALS Study, Rapid Medical aims to reach an additional 25% to 40% of stroke patients with this treatment form. The intervention targets far areas of the brain, including M3 blood vessels and allows intervention within 24 hours from onset of symptoms.

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