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 severe AR who are at high risk for surgery.
It is anticipated that the company will file for US humanitarian device exemption (HDE) approval in the second half of 2020. The company intends to continue to enrol patients in the clinical programme throughout the year to support a future premarket approval application to the FDA as part of the Breakthrough Device programme.
John Kilcoyne, CEO, comments: “We are clearly encouraged by this positive decision by the FDA regarding the expedited review of our unique TAVI system for patients suffering from severe aortic regurgitation who are at high risk for surgery and for which no transcatheter valve device is labelled or approved in the USA. We look forward to continued collaborative interactions with the FDA as we move to finalize our clinical development programme. In addition to the FDA, I would like to thank our physician investigators who are leading the clinical program to evaluate the safety and effectiveness of this important technology in the treatment of AR-dominant disease.”