Maquet Medical Systems USA announced an agreement to serve as the exclusive US distributor of InterValve V8 Aortic Valvuloplasty Balloon Catheter.
The V8 catheter is designed to be used in stand-alone balloon aortic valvuloplasty (BAV) and pre-dilatation during transcatheter aortic valve replacement (TAVR) procedures. Maquet’s sales representatives in the United States will begin selling the V8 catheter during the first quarter of 2015.
The V8 balloon catheter is designed to inflate and deflate rapidly to reduce the duration of blood flow obstruction across the valve and features a "figure-8" shape balloon that enables the bulbs at either end of the balloon to "lock" into either side of the aortic annulus.
This design has the potential to reduce the risk of balloon movement during dilatation. The V8 is the first ever valvuloplasty catheter that maintains the figure-8 shape throughout inflation which allows for leaflet hyper-extension, to create maximum valve area opening, without increasing the risk of over-stretching the annulus. The product received 510(k) clearance in February 2014.
"Stand-alone balloon aortic valvuloplasty and pre-dilatation during transcatheter aortic valve replacement procedures have been limited today by the use of dated, conventional balloon technologies," said, Mark Ungs, CEO of InterValve.
"Our V8 balloon catheter’s figure-8 shape enables it to lock in at the annulus and beneficially hyper-extend the leaflets in a way conventional balloons can’t. We look forward to this partnership with Maquet."