Surgeons Complete Clinical Trial on Novel Two-Part Heart Valve
– ValveXchange® paves way for CE mark, commercial sale of first serviceable bioprosthetic valve –
Denver, Colo., (PRWEB) June 11, 2013
Surgeons in Europe have completed clinical trials on the world´s first serviceable bioprosthetic heart valve, paving the way for the CE mark and commercial sale of an advanced heart valve that eliminates many common problems for cardiac valve patients.
Cardiac surgeons in Germany, Austria and Poland have successfully completed implants and patient enrollment in the VITAL-2 clinical trial for the Vitality Heart Valve System from ValveXchange, Inc. The system incorporates a two-piece heart valve and allows a simple two-step implant procedure that provides excellent visibility into the aortic chamber, according to John Parrish, chairman and CEO of ValveXchange. The valve enables the smaller incisions that patients are now demanding. The design of the valve also allows a surgeon to replace just the leaflet set later in life, without having to completely explant and remove the entire valve.
By resolving conflicts between conventional mechanical and tissue-based prosthetic values, the Vitality system eliminates patients´ need for complex future open-heart surgeries and high doses of anti-coagulation drugs. Currently, adult patients require repeated open-heart surgeries, as they typically receive tissue valves that wear out every 10-15 years. Younger and physically active patients often receive mechanical heart valves that do not wear out, but require lifelong high doses of anti-coagulation drugs that force a sedentary lifestyle with serious side effects.
The completion of the implants, and patient enrollment places ValveXchange on track to obtain a CE mark for the system later this year. At that point, ValveXchange will release the product for commercial sale in the European Union and in other regions of the world recognizing the CE mark. The CE mark indicates a product’s compliance with European Union requirements, and enables the free movement of products within the European Economic Area. ValveXchange will also implement the process for FDA clearance in the United States.
“This milestone represents a major achievement for ValveXchange,” says Parrish. “The completion of enrollment in the VITAL-2 trial, and the best-in-class valve performance results, substantiate the ValveXchange philosophy that better science equals better valves.”
Vitality Heart Valve System
The ValveXchange system includes a two-part valve with a permanently implanted base and an easily replaceable leaflet set. Surgeons can replace the leaflet set transapically (through the apex of the heart), accessing it by a small incision between the ribs. The system´s design allows surgeons to replace leaflets with standard, minimally invasive surgical techniques that are faster and simpler than traditional redo valve replacement surgeries, while restoring top performance at the same time.
ValveXchange heart valves provide excellent hemodynamics, long durability and leaflet exchangeability, and are easy to implant, according to Ivan Vesely, Ph.D., heart valve scientist and founder of ValveXchange. “The Vitality Heart Valve System offers simplicity, security and unprecedented visibility into the aortic space,” he says. “The hemodynamics of the Vitality valves — are excellent, particularly in the smaller valve sizes.”
ValveXchange®, Inc. (http://www.valvexchange.com)
ValveXchange®, Inc. is an emerging medical technology company serving cardiac surgeons and cardiologists. The company is the developer of the Vitality Heart Valve System, the first serviceable bioprosthetic heart valve. The company´s family of products also includes the Vitality-S sutureless valve, ideal for minimally invasive and robotic implants, and ValveXchange Vanguard transcatheter valves for the inoperable patient. All of the valves are serviceable for leaflet replacement later in life.
Based in Denver, ValveXchange holds 13 patents and has an additional 8 patent applications in process. The company´s research has been supported in part by $4 million in grants from the National Institutes of Health.
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