Cardiac surgeons in Germany, Austria and Poland have successfully completed implants and patient enrolment in the VITAL-2 clinical trial for the Vitality Heart Valve System (ValveXchange), according to a company release.
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.
ValveXchange’s CE mark approval is pending and the company have stated that, once CE-marked they will release the product for commercial sale in the European Union and in other regions of the world that recognise the CE mark. ValveXchange commented that it will also implement the process for FDA clearance in the USA.
“This milestone represents a major achievement for ValveXchange,” says Parrish. “The completion of enrolment in the VITAL-2 trial, and the best-in-class valve performance results, substantiate the ValveXchange philosophy that better science equals better valves.”