Covidien reports positive data from Solitaire FR trial

Covidien has reported positive clinical trial data from Star, a new trial assessing the safety and efficacy of its Solitaire FR revascularisation device.

The product has been designed to restore blood flow in patients experiencing acute ischaemic stroke, which is the most prevalent type of stroke worldwide, accounting for 87 percent of all recorded cases.

It was found that treatment with Solitaire FR for intracranial anterior circulation occlusions was associated with high revascularisation rates, good clinical outcomes, low mortality risk and a minimal chance of clinically relevant procedural and device-related complications.

Dr Mark Turco, chief medical officer for vascular therapies at Covidien, said: "We are pleased to report that the Star study adds to the growing body of evidence supporting the use of the Solitaire FR device as a superior tool for revascularisation in acute ischemic stroke care."

Last month, the company announced that its new EverFlex Self-expanding Peripheral Stent with Entrust Delivery System has received CE Mark approval, meaning it can now move ahead with a European launch of the device.