ValveXchange®, Inc., says it is moving a step closer to market, having submitted its application for CE mark approval. The significance of this news lies in the fact that its novel design is a sort of hybrid of conventional and transcatheter valve technology, offering in theory the best of both worlds – a conventionally inserted valve with leaflets replaceable through minimally invasive means. The device is described as the world’s first serviceable bioprosthetic heart valve.
The Vitality Aortic Pericardial Bioprosthesis™ (Vitality™) is a two-part valve, with a permanently implanted base and an easily replaceable leaflet set. Surgeons can replace the Leaflet Assembly transapically, accessing it by a small incision between the ribs.
ValveXchange says its 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 possibility of replacing just the valve leaflets later in life, without having to completely explant and remove the entire valve has the potential to obviate the need for traumatic re-do surgery which may not even be a possibility for some patients.
Interestingly, the initial CE Mark that ValveXchange is seeking for the Vitality is for identical indications and claims as conventional aortic bioprostheses, the leaflet replacement indication presumably coming later when clinical data supports it.
“The submission of the technical dossier (to notified body DEKRA) is yet another example of ValveXchange staff meeting major milestones, and driving the Vitality valve product line towards market release,” says John Parrish, chairman and CEO of ValveXchange.
“ValveXchange expects to obtain the CE Mark later this year and will seek FDA clearance in the United States.”
Source: ValveXchange, Inc., PR Web