Covidien gets Brazilian approval for stroke device

Solitaire FR revascularization device--courtesy of Covidien

After snagging 510(k) clearance in March, Covidien ($COV) is bringing its Solitaire FR revascularization tech to Brazil, getting approval from that country's National Health Surveillance Agency.

The device is designed to restore blood flow to the brain in patients who have suffered acute ischemic strokes, caused when brain-bound blood vessels get blocked by clots.

The device has been for sale in Europe since 2009, but Covidien looks forward to the sales boost Brazil's sizable market will provide, and the tech will serve a large unmet need there: Stroke is the leading cause of death in the country, according to the Brazilian Stroke Network, affecting 400,000 people a year.

Solitaire is inserted into vessels to break up clots and restore the normal flow of blood and nutrients to the brain. Covidien is touting the device as the next generation for stroke treatment, outstripping anything else on the market.

"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," principal investigator Vitor Mendes Pereira said in a statement.

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