The FDA granted 510(k) clearance to InterValve to market its V8 Aortic Valvuloplasty Balloon Catheter.
The catheter is designed to be used in stand-alone balloon aortic valvuloplasty and predilation during transcatheter aortic valve replacement procedures. In summary documents to the FDA, the company described the system as an hourglass-shaped balloon intended to allow for full dilation of stenotic aortic valve leaflets while minimizing over-dilation of the aortic annulus.
Minneapolis-based InterValve wrote that the balloon will be available in four diameter sizes, 22 mm through 28 mm, with a catheter available in working lengths of 107 cm and 113 cm compatible with a 12F or 14F introducer sheath. It is introduced through the femoral artery.