Maquet Medical Systems USA entering exclusive US distribution agreement for InterValve Inc.'s V8™ aortic valvuloplasty balloon catheter utilized in transcatheter aortic valve replacement (TAVR) procedures
Maquet Medical Systems USA announced today an agreement to serve as the exclusive US distributor of InterValve Inc.’s 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, Inc. “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.”
Raoul Quintero, President and CEO Maquet North America, said, "We’re seeing our customers look to BAV and TAVR as alternatives to surgical aortic valve replacement. In particular, technology improvements, operator and team experience, and continued research have resulted in increased interest and growth in transcatheter aortic valve replacement. We’re excited to be able to offer the V8 catheter as part of our mission to support our customers in delivering the highest standards of care.”
Maquet, a trusted partner for hospitals and physicians for more than 175 years, is a global leader in medical systems. The company offers innovative therapy solutions and infrastructure capabilities for high-acuity areas within the hospital — including the operating room (OR), hybrid OR/cath lab, and intensive care unit (ICU) — as well as intra- and inter-hospital patient transport. Additionally, Maquet develops intelligent and sustainable room concepts that exceed the expectations of modern hospitals, working in close cooperation with customers, production engineers and architects to integrate high quality products and services.
Headquartered in Rastatt, Germany, Maquet is the largest subsidiary of the publicly listed Getinge Group AB of Sweden. Maquet generated about 1.54 billion Euros in 2013, representing more than half of the Getinge Group’s annual revenue of 2.9 billion Euros. Maquet has 6,550 employees and provides 40 international sales and service organizations, as well as a network of more than 300 sales partners.
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.