Solitaire FR revascularisation device receives regulatory approval in Canada


Covidien has announced that the Solitaire FR revascularisation device has been approved by Health Canada. The Solitaire FR is a mechanical thrombectomy device designed to retrieve blood clots and restore blood flow to the brain for patients suffering from acute ischaemic stroke.

“This new device is taking acute ischaemic stroke care to a new level,” said Mayank Goyal, interventional neuroradiologist, Foothills Medical Centre, Calgary, Canada, and principal investigator of workflow and imaging for the SWIFT-Prime (Solitaire FR as primary treatment for acute ischaemic stroke) study. “It clearly surpasses the first generation of clot-removing procedures, which were only moderately successful in reopening target arteries, and gives us a far superior tool for revascularisation in stroke patients.”

According to the BURST (Canadian Stroke Network’s burden of ischaemic stroke) study, the healthcare costs for patients in Canada in the first six months after they have a stroke is more than CAD$2.5 billion a year.

“Stroke is a widespread public health issue, with approximately 50,000 Canadians experiencing a stroke annually,” said Stacy Enxing Seng, president, Vascular Therapies, Covidien. “Solitaire FR is intended to transform the way this potentially fatal and often debilitating condition is treated.”

The Solitaire FR device received CE Mark approval in Europe and has been sold in that region by Covidien since November 2009. Solitaire FR is also available in the USA, where it received US Food and Drug Administration (FDA) clearance in March 2012.