On March 26, 2024, the exciting results of JenaValve TrilogyTM System’s pivotal clinical trial, ALIGN-AR, were published in the prestigious medical journal THE LANCET. The ALIGN-AR trial met prespecified non-inferiority criteria for its primary safety endpoint and primary efficacy endpoint. Also, results demonstrated that the TrilogyTM THV system showed a high technical success rate and promising safety profile. Also, patients treated with TrilogyTM can effectively reverse cardiac damage caused by pure aortic regurgitation.
The ALIGN-AR trial is a prospective, multicenter, single-arm, investigational device exemption (IDE) study evaluating the use of JenaValve’s TrilogyTM transcatheter heart valve in high-risk patients with symptomatic moderate-to-severe or severe aortic regurgitation. Peijia Medical entered into a collaboration and license agreement with JenaValve in December 2021. Peijia Medical is entitled to develop, manufacture, and commercialize the TrilogyTM THV System in the Greater China region. Peijia Medical has completed the patient enrollment of multi-center registration clinical trial for TaurusTrioTM in mainland China and the patient follow-up is on going.
