ValveXchange submits 2-part heart valve for EU approval

07/19/2013 | (Boston)

ValveXchange has filed a CE mark approval application in Europe for its Vitality system, a heart valve specially designed in two parts to allow the frame to remain in the heart while the leaflet is exchanged during device maintenance without requiring open heart surgery. The company, which is also navigating its way through the FDA regulatory process, anticipates CE mark approval for the device this year.

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