Covidien has completed enrolling the first patient in SWIFT PRIME trial of its Solitaire FR Revascularisation device, designed to restore blood flow, administer medical therapy as well as retrieve clot in patients with acute ischemic stroke.
The controlled, multi-center, prospective, randomized clinical trial will enroll 800 patients to examine acute ischemic stroke patients treated with either intravenous tissue plasminogen activator (IV tPA) alone or IV tPA in combination with the company’s Solitaire device.
University at Buffalo neurosurgery and radiology professor and Interventional Stroke Services director Elad Levy said, "We hope this study will help better understand the patient population that most benefits from thrombolysis combined with mechanical thrombectomy."
Covidien vascular therapies chief medical officer Mark Turco said the Solitaire FR device shows substantial improvements in outcomes over previous mechanical thrombectomy treatments.
"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," Turco added.
"We also look forward to the insights that the study will provide into critical components of stroke treatment, such as time and imaging."