InterValve's V8 Aortic Valvuloplasty Balloon Catheter Approved by FDA

April 26, 2013—InterValve Inc. (Minneapolis, MN) announced that it received US Food and Drug Administration 510(k) clearance to market the V8 aortic valvuloplasty balloon catheter in the United States. The V8 catheter is designed for use in standalone balloon aortic valvuloplasty and in predilation during transcatheter aortic valve replacement procedures.

According to the company's press release, the V8 balloon catheter features a figure 8–shaped balloon that enables the bulbs at either end of the balloon to lock into either side of the aortic annulus. The design has the potential to reduce the risk of balloon movement during dilatation, thereby reducing procedure and ischemic time. The noncompliant material maintains the figure 8 shape throughout inflation, which allows for leaflet hyperextension to create maximum valve area opening without increasing the risk of overstretching the annulus. The catheter is designed to inflate and deflate rapidly to reduce the duration of blood flow obstruction across the valve, according to InterValve.