Denver, Colo. (PRWEB) July 17, 2013
ValveXchange®, Inc., has submitted the European product approval application for the world’s first serviceable bioprosthetic heart valve, moving a step closer to commercial sale of an advanced heart valve that eliminates many common problems for cardiac valve patients.
DEKRA Certification, the notified body to which ValveXchange submitted the application, will determine whether the Vitality Aortic Pericardial Bioprosthesis™ (Vitality™) meets the standards for the CE Mark. The mark, indicating a product's compliance with European Union requirements, enables the free movement of products within the European Economic Area. Once the Vitality valve receives the mark, ValveXchange will be able to release the product for commercial sale in the European Union and in other regions of the world recognizing the CE mark. The initial CE Mark that ValveXchange is seeking for the Vitality is for identical indications and claims as conventional aortic bioprostheses.
The submission for the Vitality follows the completion of European clinical trial enrollment in June. The valve is part of the ValveXchange Vitality Heart Valve System™. Incorporating the two-piece heart valve, the system allows a simple two-step implant procedure that provides excellent visibility into the aortic valve anatomy, according to John Parrish, chairman and CEO of ValveXchange.
“The submission of the technical dossier to DEKRA is yet another example of ValveXchange staff meeting major milestones, and driving the Vitality valve product line towards market release,” says Parrish. ValveXchange expects to obtain the CE Mark later this year, he adds. The company also will seek FDA clearance in the United States.
“The product approval application submission is a significant regulatory achievement capping months of preparation effort,” adds Kevin Morningstar, senior director of quality assurance and regulatory affairs for ValveXchange. “Developing a rationale to demonstrate that the Vitality is safe and effective was straight-forward,” he says, citing the company’s involvement of DEKRA early in the planning stages and the organization’s fast, responsive work. “Working with DEKRA has been a real pleasure.”
Vitality Heart Valve System
The Vitality is a two-part valve, with a permanently implanted base and an easily replaceable leaflet set. Surgeons can replace the Leaflet Assembly 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, restoring top performance at the same time. The valve enables the smaller incisions that patients are now demanding. The design allows a surgeon to replace just the Leaflet Assembly later in life, without having to completely explant and remove the entire valve.
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 14 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.