Covidien Solitaire FR revascularisation device accepted for global trial

Covidien's Solitaire FR revascularisation device has received approval for investigational use in a forthcoming clinical study among stroke patients.

The unit is set to be utilised in the thrombectomy arm of the new IMS III Interventional Management of Stroke trial, which will evaluate the benefits of an intravenous and intra-arterial treatment approach to restoring blood flow to the brain.

Involving around 900 subjects with moderate to severe ischemic stroke in the US, Canada, Australia and potentially Europe, it will compare the effectiveness of this treatment method to intravenous recombinant tissue plasminogen activator therapy alone.

This study will support the approval of Solitaire FR in the US, as the device has already become the leading technology for the endovascular treatment of acute ischemic stroke in Europe.

Dr Mark Turco, chief medical officer for vascular therapies for Covidien, said: "We look forward to the important results that will follow from this study around the optimal treatment of acute ischemic stroke."

Last month, the company published its first quarter financial report for the 2012 fiscal year, reporting a five percent year-on-year growth in sales.