Covidien receives Brazilian approval for Solitaire FR Revascularization Device

Covidien, a leading global provider of healthcare products, today announced that the Solitaire™ FR Revascularization Device has been approved by Brazil's National Health Surveillance Agency. The Solitaire FR device is used to restore blood flow to the brain in patients suffering acute ischemic stroke.

"This new device is taking acute ischemic stroke care to a new level," said Dr. Vitor Mendes Pereira, Department Chairman at Geneva University Hospital in Geneva, Switzerland, and Principal Investigator for the Solitaire FR 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 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 Brazilian Stroke Network, stroke is the leading cause of death in Brazil.

"Stroke is a widespread public health issue, with approximately 400,000 Brazilians experiencing an acute ischemic 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 market by Covidien since November 2009. Solitaire FR is also available in the U.S., where it received U.S. Food and Drug Administration clearance in March 2012.

Source: COVIDIEN