Covidien (NYSE:COV) enrolled the 1st patient in the Swift Prime study, a multi-center, randomized, controlled trial of its Solitaire FR revascularization device for restoring blood flow to the brain.
The study will enroll up to 800 patients in 60 centers around the world, comparing acute ischemic stroke patients treated with intravenous tissue plasminogen activator alone with the Solitaire FR, according to a press release.
"Technological innovation in mechanical thrombectomy represents one of the most promising new developments in stroke treatment," vascular therapies CMO Dr. Mark Turco said in prepared remarks. "The Swift Prime study is an important step in assessing both the clinical and economic value of our newest innovation in this area, underscoring Covidien’s commitment to the advancement of stroke care."
The Solitaire FR won 510(k) clearance in the U.S. last year and a CE Mark in 2009, according to the release.
Covidien earlier this month unveiled 5-year outcomes for its ClosureFast ablation study in patients with chronic venous insufficiency.