Brazilian Approval For Covidien’s Solitaire FR Revascularization Device

In short

Covidien, has 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 and received FDA approval back in March as reported on our pages here.


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.

Covidien’s Solitaire FR device is a stent-like expanding bare metal “basket” which captures and retrieves clots in the neurovascular system. We have reported extensively on the progress of clinical trials with the device and US FDA’s March approval for sale.

Clinician comments

“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.”

Company comments 

“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.”

Regulatory status

The Solitaire FR device gained CE Mark approval and has been marketed in Europe since November 2009. The device received U.S. Food and Drug Administration clearance in March 2012.

Source: Covidien