InterValve (Minneapolis, MN) won 510(k) clearance from the FDA to bring to market its V8 aortic valvuloplasty balloon catheter. The device elegantly solves the problem of balloon slippage when dilating the aortic valve during valvuloplasty, whether as its own procedure or in preparation for transcatheter aortic valve replacement (TAVR).
The balloon’s center is positioned at the valve’s opening with the help of a radiopaque marker. Once aligned, the balloon is inflated, taking on the shape of an 8, hence its name. The shape of the balloon helps to keep it in place and gives physicians the comfort of inflating the balloon to the necessary pressure without worry that it will slip out.
Product page: V8 Aortic Valvuloplasty Balloon Catheter…
Press release: INTERVALVE INC. RECEIVES 510(k) CLEARANCE IN THE UNITED STATES FOR THE V8™ AORTIC VALVULOPLASTY BALLOON CATHETER
