St. Jude Medical Inc announced the first U.S. implants of its Symmetry Bypass System Aortic Connector, a sutureless anastomosis device for coronary artery bypass grafting (CABG) surgery. The Symmetry Bypass System Aortic Connector was developed by the St. Jude Medical Cardiac Surgery Division - Anastomotic Technology Group (ATG).
Two procedures were performed at Mayo Clinic in Rochester, Minn., on May 24, 2001, following U.S. Food and Drug Administration (FDA) 510(k) clearance to commercially market the Aortic Connector. The patients are fine and recovering normally.
Dr. Kenton Zehr, Assistant Professor of Cardiac Surgery at Mayo Clinic, performed the first two procedures and has subsequently completed three more using both on-pump and off-pump techniques.
More than 750,000 coronary bypass procedures are performed annually worldwide, requiring multiple connections (anastomoses) between the vein grafts and the aorta (proximal connection) and coronary arteries (distal connection) of the heart. The Aortic Connector allows cardiac surgeons to attach vein grafts to the aorta without sutures. This device is the first in a line of mechanical connectors and delivery systems St. Jude Medical is developing for the CABG market.
"This is really a story about a high-powered engineering team working shoulder to shoulder with a few visionary surgeons, to change the world of cardiac surgery. We are delighted with the results and excited about the potential impact of our products," said Daniel J. Sullivan, President of St. Jude Medical's Anastomotic Technology Group.
"We're very fortunate and pleased to work directly with surgeons on our anastomotic devices and other technologies," said Steven J. Healy, President of St. Jude Medical's Cardiac Surgery Division. "Through our heart valve business, St. Jude Medical has a long history of excellent relationships with cardiac surgeons. We can now offer these doctors an important new device for bypass surgery, which represents the vast majority of their cardiac surgery cases."
The Symmetry Bypass System Aortic Connector has been available in Europe since receiving CE Marking in May 2000, in a controlled market release in 55 centers with over 1000 implants. The second product in the Symmetry Bypass System, the Coronary Connector, was first implanted in November 2000 and is currently in clinical evaluation outside the United States.