Medtronic Stent Receives FDA Approval
Fridley-based Medtronic, Inc., announced Monday that a stent it develops to repair thoracic aortic aneurysms has received approval from the U.S. Food and Drug Administration.
The stent, called Talent Thoracic Stent Graft with Captivia Delivery System, is used in the endovascular repair of thoracic aortic aneurysms (TAA)-which are dangerous bulges in the body's main artery that can rupture with fatal consequences if left untreated.
Medtronic said that an estimated 60,000 people in the United States have a TAA, but only about half are ever diagnosed due to lack of symptoms.
The Talent Captivia System is inserted into the femoral artery in the patient's groin during thoracic endovascular aortic repair. It is then moved up through blood vessels to the aorta.
When the device reaches the site of the aneurysm, a physician expands the stent graft within the aorta, creating a new path for blood flow, which reduces pressure on the bulge and the risk of rupture.
“The Captivia Delivery System's tip capture mechanism is designed to provide excellent control of the stent graft during deployment to ensure that blood flow isn't occluded into the nearby arteries,” Dr. Edward Y. Woo, vice-chief and program director of vascular surgery and endovascular therapy for the University of Pennsylvania Hospital System, said in a statement. “This improvement to the delivery system also increases my confidence in the device's deployment accuracy.”
Medtronic is Minnesota's ninth-largest public company based on revenue for the fiscal year that ended in April 2009, which totaled $14.6 billion. The company reported revenue of $15.82 billion in its most recently completed fiscal year.