Healthcare products company Covidien has enrolled the first patient in a controlled, multi-centre, prospective, randomised clinical trial to examine the adjunctive use of its mechanical thrombectomy device during the early stages of acute ischemic stroke.
The FDA-approved and CE-marked Solitaire FR Revascularisation device is designed to restore blood flow, administer medical therapy, as well as retrieve clot in patients experiencing acute ischemic stroke.
The trial, named SWIFT PRIME, will enrol 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."
Image: Solitaire FR Revascularisation device restores blood flow, administers medical therapy, as well as retrieves clot in patients experiencing acute ischemic stroke. Photo: courtesy of Covidien.