FDA 510(k) Clearance For InterValve’s V8 Aortic Valvuloplasty Balloon Catheter

IntervalveIn short

In case you hadn’t come across InterValve Inc., this early stage company spends its time perfecting the art of aortic valvuloplasty balloon catheter design. Already with a CE mark under its belt, the company has now received FDA 510(k) clearance to market the clever V8™ Aortic Valvuloplasty Balloon Catheter in the United States.


Calcific aortic stenosis (AS) is the most common cause of acquired valvular heart disease in the Western world with substantial morbidity and mortality.

Surgical aortic valve replacement is the definitive treatment for AS with universally recognized symptomatic relief and almost full restoration of age-adjusted life expectancy. However, a significant number of symptomatic AS patients forgo surgical valve replacement due to risk of complications. Balloon Aortic Valvuloplasty(BAV), the act of dilating stenosed valve leaflets using a balloon, can provide immediate symptom relief, but is not a long term durable solution as the leaflets tend to re-stenose. For this reason it is increasingly used as a precursor to transcatheter aortic valve implantation(TAVI), pre-dilating the valve leaflets prior to insertion of a new valve.

InterValve has clearly spotted a niche if it can improve on existing balloon design. The company’s V8™ catheter is designed to be used in both stand-alone BAV, and pre-dilation during transcatheter aortic valve implantation (TAVI) procedures.

Why V8? Well, the balloon catheter 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. The non-compliant material 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.

InterValve also says V8’s design has the potential to reduce the risk of balloon movement during dilatation, thereby reducing procedure and ischemic time.

Company comments

“These procedures are limited today by the use of dated, conventional balloon technologies. The shape and material properties of the V8™ balloon catheter are designed to enhance both procedures through reduction in balloon movement and optimized leaflet expansion without over distention of the annulus,” said Mark Ungs, Chief Executive Officer of InterValve.

Source: InterValve, Inc., Business Wire