New Device for Heart Surgery
A new medical device is approved for use during balloon angioplasty to help keep heart arteries from closing again, FDA announced last June 2. This reclosing occurs in 2 to 11 percent of patients.
The Gianturco-Roubin Flex-Stent Coronary Stent is an implantable, tube-shaped stainless steel mesh device about 1 inch long. It remains inside the artery walls as a "scaffold" to improve blood flow.
About 300,000 balloon angioplasties are performed each year in patients with atherosclerosis, a progressive disease in which heart arteries become blocked with fatty plaque, causing chest pain, heart attack, and death.
In balloon angioplasty on the heart, the surgeon threads a balloon-tipped catheter through a leg or arm artery to the heart artery. When the catheter reaches the blockage, the surgeon inflates the balloon to compress the plaque against the artery walls, then deflates it, and withdraws the catheter. If the artery closes or threatens to close, the surgeon withdraws the first balloon catheter and inserts a stented balloon catheter. …