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


4/30/2013 7:23:22 AM

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MINNEAPOLIS--(BUSINESS WIRE)-- InterValve Inc., an early stage medical device company dedicated to advancing innovations in aortic valvuloplasty balloon catheter design, announced today 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 hyper-extension, 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.

ABOUT BALLOON AORTIC VALVULOPLASTY (BAV) AND TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR)

Calcific aortic stenosis (AS) is the most common cause of acquired valvular heart disease in the Western world with substantial morbidity and mortality. While patients can survive for years with asymptomatic AS, the prognosis following symptom onset is quite poor without intervention. 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.

In a BAV procedure a balloon catheter is placed across the valve and the leaflets are dilated with balloon inflation. This procedure can provide immediate symptom relief, but is not a long term durable solution as the leaflets tend to re-stenose.

TAVR is a new catheter based procedure that delivers a prosthetic valve via the femoral artery, but sometimes transapically. In a TAVR procedure a balloon catheter is first delivered across the native valve to pre-dilate the valve leaflets before the prosthetic valve is delivered and implanted.

Both procedures can be compromised by dilation balloon slippage during inflation, and damage to the valvular annulus by over distension.

ABOUT INTERVALVE INC.

InterValve Inc. is headquartered in Minneapolis, Minnesota. The company is dedicated to advancing innovations in aortic valvuloplasty balloon catheter design that improve procedure safety and efficacy.

Contact:

InterValve Inc.

Mr. Mark Ungs, 952-303-3539

Chief Executive Officer



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