Jul 20 2012
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