Medtronic gets US clearance for breathing system
FDA OKs Medtronic's Affinity Fusion breathing machine for patients undergoing heart surgery
MINNEAPOLIS (AP) -- Medical device maker Medtronic Inc. said Tuesday it received U.S. clearance for a new artificial lung system that breathes for patients who are undergoing open heart surgery.
The Food and Drug Administration cleared the company's Affinity Fusion oxygenation system, which is designed to oxygenate and remove carbon dioxide from the blood. Each year about 1 million patients worldwide undergo cardiopulmonary bypass surgery, a procedure in which the heart and lungs are temporarily stopped, according to Medtronic.
The device has already been used in surgical procedures at the Cleveland Clinic and the Heart Hospital Baylor Plano, in Plano, Texas.
European regulators approved the Affinity Fusion system last September.
Shares of Medtronic Inc. rose 32 cents to $47.12 in morning trading.
