ValveXchange is eyeing CE Mark approval in the European Union for its 2-part heart valve, which the company touts as the 1st serviceable bioprosthetic heart valve.
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.
