Technology | May 01, 2013

InterValve Receives 510(k) Clearance for V8 Aortic Valvuloplasty Balloon Catheter

 V8 Aortic Valvuloplasty Balloon Catheter InterValve

May 1, 2013 — InterValve Inc. announced that it has received 510(k) clearance to market the new V8 Aortic Valvuloplasty Balloon Catheter in the United States.

The V8 catheter is designed to be used in stand-alone balloon aortic valvuloplasty (BAV), and pre-dilation during transcatheter aortic valve replacement (TAVR) procedures.

“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.

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. This design has the potential to reduce the risk of balloon movement during dilatation, thereby reducing procedure and ischemic time.

The non-compliant material maintains the figure-8 shape throughout inflation, which allows for leaflet hyperextension, to create maximum valve area opening, without increasing the risk of over-stretching the annulus.

Lastly, the catheter is designed to inflate and deflate rapidly to reduce the duration of blood flow obstruction across the valve.

For more information:

Related Content

Cardiovascular Systems Expands Product Portfolio for Peripheral and Coronary Interventions
News | Balloon Catheter | January 24, 2018
Cardiovascular Systems Inc. recently announced two new partnerships broadening the company’s product portfolio. CSI is...
Abbott recalls its NC Balloon catheters
News | Balloon Catheter | May 22, 2017
May 22, 2017 — Abbott Vascular has initiated a voluntary recall of specific lots of three catheters due to 19 reports
Videos | Balloon Catheter | November 16, 2016
A discussion with Todd Brinton, M.D., about the newly FDA-cleared Shockwave Medical Lithoplasty System, at the Transc
NuCryo Vascular, Next Generation Cryoplasty Inflation Device, PolarCath Balloon Dilatation System

PolarCath Balloon Dilatation System image courtesy of NuCryo Vascular

Technology | Balloon Catheter | March 28, 2016
NuCryo Vascular LLC announced the launch of the Next Generation Cryoplasty Inflation device. The device received U.S....
NuCryo Vascular, FDA clearance, next-gen, PolarCath System, cryoplasty inflation device
Technology | Balloon Catheter | January 12, 2016
NuCryo Vascular LLC announced that they have received U.S. Food and Drug Administration (FDA) 510(k) clearance on the...
Videos | Balloon Catheter | October 30, 2015
Todd Brinton, M.D., clinical associate professor and consulting associate professor of bioengineering at Stanford Uni
Overlay Init