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| Covidien gained Canadian approval for its Solitaire FR device--courtesy of Covidien |
Covidien ($COV) is expanding the reach of its Solitaire FR revascularization device, snagging approval from Health Canada for the stroke-fighting tech.
Solitaire is designed to restore blood flow to the brain in patients suffering acute ischemic stroke by mechanically removing blood clots from blocked vessels, and the latest approval follows a 2009 CE mark and 510(k) clearance earlier this year.
Covidien conducted a Canadian study to support its approval application, and principle investigator Mayank Goyal said Solitaire will be the best option on the market for the roughly 50,000 Canadians who suffer strokes each year.
"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," Goyal said in a statement.
Over the summer, Covidien got Brazilian approval for the device, allowing the company to cash in on a huge unmet need in the country. Stroke is the leading cause of death in Brazil, according to the Brazilian Stroke Network, affecting 400,000 people a year.
- read Covidien's announcement