Covidien's stroke device moves SWIFTly to FDA queue for approval
After a recommendation from the Data Safety Monitoring Board (DSMB) following promising results, Covidien has stopped enrollment into its SWIFT trial, which is investigating the use of the Solitaire FR revascularization device. The company said it will take the trial data directly to FDA in hopes of approval.
The Dublin, Ireland-based company said that it is hoping for approval from the FDA to use the device to help restore blood flow in acute ischemic stroke patients within eight hours of symptom onset. Covidien’s Solitaire received CE mark in 2009 and the SWIFT (Solitaire FR With Intention For Thrombectomy) trial enrollment began in March 2010 in the U.S.
The company said that it will continue to conduct follow-up in the patients already enrolled in the trial, and in the meantime will collaborate with the FDA for the next steps to obtain a 510(k) clearance.
The aim of the randomized SWIFT trial was to evaluate the safety and efficacy of the Solitaire device compared with the Merci Retrieval System (Concentric Medical) in 200 patients with acute ischemic stroke. The primary endpoint was arterial recanalization of occluded target vessel measured by a TIMI score of 2 or 3 following the use of either device without symptomatic intracranial hemorrhage.
The Solitaire device became part of Covidien’s device portfolio after a merger agreement in July where Covidien acquired ev3 vascular and endovascular platforms.
The Dublin, Ireland-based company said that it is hoping for approval from the FDA to use the device to help restore blood flow in acute ischemic stroke patients within eight hours of symptom onset. Covidien’s Solitaire received CE mark in 2009 and the SWIFT (Solitaire FR With Intention For Thrombectomy) trial enrollment began in March 2010 in the U.S.
The company said that it will continue to conduct follow-up in the patients already enrolled in the trial, and in the meantime will collaborate with the FDA for the next steps to obtain a 510(k) clearance.
The aim of the randomized SWIFT trial was to evaluate the safety and efficacy of the Solitaire device compared with the Merci Retrieval System (Concentric Medical) in 200 patients with acute ischemic stroke. The primary endpoint was arterial recanalization of occluded target vessel measured by a TIMI score of 2 or 3 following the use of either device without symptomatic intracranial hemorrhage.
The Solitaire device became part of Covidien’s device portfolio after a merger agreement in July where Covidien acquired ev3 vascular and endovascular platforms.