JenaValve Technology, Inc. announced FDA approval for an investigational device exemption (IDE) trial – ALIGN AR – for treatment of aortic regurgitation (AR). ALIGN-AR pivotal trial will enroll patients with severe symptomatic AR who are at high surgical risk to be treated with the Trilogy TAVR valve platform. JenaValve received CE mark approval in Europe earlier this year for treatment of severe symptomatic aortic stenosis or aortic regurgitation in high surgical risk patients. The ALIGN-AR trial will enroll patients to assess the safety and effectiveness of the Trilogy device and will be conducted to support a premarket approval application.

All Editors: Jared M. O’Leary, MD