Covidien, a medical supply and equipment company incorporated in Dublin, Ireland, received approval from Health Canada for its Solitaire FR revascularization device. The Solitaire FR device is designed to remove clots and restore blood flow in acute ischemic stroke victims.
Approval of the device in Canada follows several other regulatory wins over the past year. In March, the United States Food and Drug Administration (FDA) cleared the device following the Covidien Swift study. This novel study directly compared mechanical interventions for patients suffering from acute ischemic stroke. The company also received CE Mark regulatory approval for the device in the European Union in 2009.
The Covidien Swift study started in 2010. This study was designed to compare’s Covidien’s Solitaire technology against the Merci Retriever by Concentric Medical, a device that had already received FDA clearance.
Acute ischemic strokes occur when blood vessels in the brain are blocked by a clot. Six-month care for stroke patients costs the taxpayer-subsidized Canadian healthcare system more than $2.5 billion every year.
Stacy Enxing Seng is president of the vascular therapies division at Covidien. In prepared remarks, she said, “Stroke is a widespread public health issue, with approximately 50,000 Canadians experiencing a stroke annually.” She continued, "Solitaire FR is intended to transform the way this potentially fatal and often debilitating condition is treated."