FDA grants Maquet Cardiovascular 510(k) clearance for its CardioRoot aortic graft


June 3, 2011
The U.S. Food and Drug Administration (FDA) has granted Maquet Cardiovascular 510(k) clearance to market its CardioRoot aortic graft in the United States. A one-piece design, aortic root graft, CardioRoot will be used by vascular and cardiovascular surgeons to surgically repair or replace diseased and damaged aortae. CardioRoot is now commercially available in the United States.

CardioRoot’s design mimics the anatomy of the patient’s native aortic root, including the clinically important natural sinuses of valsalva, which supply blood to the heart’s own arteries. CardioRoot’s anatomically correct shape allows easy sewing of valve remnants or a prosthetic valve within the tube, thereby avoiding potential bleeding while shortening surgical procedure time.

For more information: www.maquet.com