Medtech giant Covidien (NYSE:COV) won Health Canada approval for its Solitaire FR revascularization device, intended to remove blood clots and restore blood flow in the brains of patients suffering acute ischemic stroke.
"Stroke is a widespread public health issue, with approximately 50,000 Canadians experiencing a stroke annually," president of vascular therapies Stacy Enxing Seng said in prepared remarks. "Solitaire FR is intended to transform the way this potentially fatal and often debilitating condition is treated."
The FDA cleared Solitaire in March on the basis of data gathered during Covidien’s Swift study, the first of its kind to compare mechanical interventions for acute ischemic stroke. The company has had CE Mark approval for the device in the European Union since 2009.
The company took a bit of a gamble in March 2011 when deciding to wrap up the Swift trial ahead of schedule with an eye toward speedy market approval, but the measure paid off with news of the FDA’s green light.
The Swift studies began recruiting stroke patients in 2010, comparing the Solitaire system against Concentric Medical’s already-cleared Merci Retriever.
The company in July received regulatory approval in Brazil for the device.
An acute ischemic stroke can occur when a blood vessel that carries oxygen and nutrients to the brain is blocked by a clot and the flow of blood to the brain is interrupted, the company said.
Providing 6-month care for stroke patients costs the Canadian healthcare system upwards of $2.5 billion a year, according to the Canadian Stroke Network’s Burden of Ischemic Stroke study.