Healthcare products company Covidien has received Health Canada's approval for its revascularization device.
The FDA-cleared and CE mark approved Solitaire FR device restores blood flow to the brain in patients with acute ischemic stroke, occurring in 50,000 Canadians annually.
The healthcare costs for patients in just the first six months after having a stroke is more than $2.5bn a year in Canada, according to the Canadian Stroke Network’s Burden of Ischemic Stroke (BURST) study.
Foothills Medical Centre interventional neuroradiologist and Solitaire FR as Primary Treatment for Acute Ischemic Stroke (SWIFT-Prime ) study workflow and imaging principal investigator Mayank Goyal said, "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 revascularization in stroke patients."
Covidien vascular therapies president Stacy Enxing Seng said, "Solitaire FR is intended to transform the way this potentially fatal and often debilitating condition is treated."