Valvuplasty balloon catheter receives 510(k) clearance in the US
A figure-8 valvuplasty balloon catheter has received 510(k) clearance in the US
An early stage medical device company has revealed its aortic valvuplasty balloon catheter design has received 510(k) clearance to market in the US.
The V8 catheter has been designed to be used in a stand-alone aortic valvuplasty and pre-dilation during transcatheter aortic valve replacement procedures.
Chief executive of InterValve, the group behind the design, Mark Ungs, explained that conventional balloon technologies are limiting these replacement procedures.
He said: "The shape and material properties of the V8 balloon catheter are designed to enhance both procedures through reduction in balloon movement and optimised leaflet expansion without over distention of the annulus."
Featuring a figure-8 shape balloon, the design allows bulbs at either end of the balloon to "lock" into either side of the aortic annulus.
According to a statement from InterValve, the design has the potential to decrease the risk of balloon movement during dilation, reducing procedure and ischemic time.
InterValve has its headquarters in Minneapolis, Minnesota, and aims to improve procedure safety and efficacy.
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