Covidien's Solitaire FR Approved in Canada to Treat Acute Ischemic Stroke

December 13, 2012—Covidien (Mansfield, MA) announced that the company's Solitaire FR revascularization device has received regulatory approval from Health Canada. The Solitaire FR revascularization device is intended to restore blood flow to the brain in patients with acute ischemic stroke by mechanically removing blood clots from blocked vessels.

According to the company, the Solitaire FR device has received CE Mark approval in Europe, where Covidien has marketed it since November 2009, and it is also available in the United States, where it received US Food and Drug Administration clearance in March 2012.

Covidien advised that the Canadian Stroke Network's Burden of Ischemic Stroke (BURST) study has estimated that the healthcare costs for stroke patients in the first 6 months is more than $2.5 billion a year in Canada, where approximately 50,000 people experience a stroke annually.

In the company's press release, Mayank Goyal, MD, Principal Investigator of Workflow and Imaging for the SWIFT Prime (Solitaire FR as Primary Treatment for Acute Ischemic Stroke) study, commented, "This new device is taking acute ischemic stroke care to a new level. 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.” Dr. Goyal is an interventional neuroradiologist at Foothills Medical Center in Calgary, Canada.