Maquet's Cardioroot Surgical Aortic Graft Cleared in US and EU

May 19, 2011—Maquet Cardiovascular (Wayne, NJ) announced that the US Food and Drug Administration has granted 510(k) clearance for the company to market its Cardioroot aortic root graft in the United States. The company also announced that it has received European CE-Mark approval for the device. The one-piece device is designed for the surgical repair or replacement of diseased and damaged aortae. The Cardioroot is now commercially available in the United States. It is expected to be commercially available in the European Union within the next 60 days.

According to the company, the device mimics the anatomy of the patient's native aortic root, including the clinically important natural sinuses of Valsalva. Its 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.

"The Cardioroot graft is an important option for aortic root repair,” commented cardiothoracic surgeon Marc W. Gerdisch, MD. “The graft wall is supple, allowing better approximation with tissue. The unique properties of the graft material provide ease of suturing and superb predictability of the final geometry. The improved hemostasis is an added advantage of Cardioroot for complex aortic root reconstructions, substantially contributing to a dry surgical field at the end of the surgery.”