News | December 20, 2012

Covidien’s Solitaire FR Revascularization Device Receives Regulatory Approval in Canada

Device helps restore blood flow to the brain after a stroke, may help doctors save more lives

Covidien Soltaire FR Thrombectomy Devices Stroke Treatment

December 20, 2012 — Covidien announced that the Solitaire FR Revascularization Device has been approved by Health Canada. The Solitaire FR device is used to restore blood flow to the brain in patients suffering from acute ischemic stroke.

"This new device is taking acute ischemic stroke care to a new level," said Dr. Mayank Goyal, interventional neuroradiologist at Foothills Medical Centre in Calgary, Canada, and principal investigator of Workflow and Imaging for the SWIFT-Prime (Solitaire FR as Primary Treatment for Acute Ischemic 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 revascularization in stroke patients.”

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

“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 United States, where it received U.S. Food and Drug Administration clearance in March 2012.

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