JenaValve TAVI system designated by FDA as “Breakthrough Device”

JenaValve   JenaValve Technology has received “Breakthrough Device” designation from the FDA. This designation is for severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease. The company is the sponsor of a US investigational device exemption (IDE) trial and is conducting a multicentre clinical programme for the treatment of patients with [...]