ValveXchange has its sights set on winning regulatory approval in Europe for its Vitality device, a product the company touts as the 1st serviceable bioprosthetic heart valve.
Clinical trial enrollment to support European CE Mark approval wrapped up last month, and ValveXchange submitted all of its paperwork to the regulatory body DERKA Certification this week, according to a press release.
The Denver, Colo.-based company’s Vitality device operates like a traditional leaflet transcatheter valve but has been specifically engineered in 2 parts.
During routine maintenance of the device, the frame remains in the heart and a worn-out leaflet can be exchanged without open-heart surgery or cardiopulmonary bypass.
"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," said CEO John Parrish in prepared remarks.
The company is expecting CE Mark this year and is also working its way through the U.S. FDA regulatory process.
