JenaValve Receives IDE Approval to Initiate the ALIGN-AR Pivotal PMA Trial

August 16, 2021—JenaValve Technology, Inc. announced approval from the FDA to initiate the company’s investigational device exemption (IDE) clinical trial, ALIGN-AR, which will be conducted to support a premarket approval application for the Trilogy heart valve system for transcatheter aortic valve replacement (TAVR) to treat high surgical–risk patients with severe, symptomatic aortic regurgitation (AR).

According to the company, the ALIGN-AR pivotal trial will enroll patients to assess the safety and effectiveness of the Trilogy device in this treatment. The study design also allows for enrollment of patients both in and outside of the United States.

The Trilogy device is currently limited by federal law to investigational use in the United States, where the current treatment for high surgical–risk patients who are not candidates for open-heart surgery consists predominantly of medical management and off-label TAVR, noted the company.

On May 25, the company announced that it had received CE Mark approval for the transfemoral Trilogy TAVR system for the treatment of severe, symptomatic AR and aortic stenosis in patients at high surgical risk. The system is available in Europe in three sizes, enabling the treatment of a broad range of annular diameters. On June 15, the company announced that the 100th patient had been enrolled in the prospective, multicenter clinical ALIGN-AR trial.