The data from the trial will support the premarket approval application with the US Food and Drug Administration (FDA). Image Credit: mybox / Shutterstock.

JenaValve Technology’s Trilogy transcatheter heart valve system met the prespecified non-inferiority criteria for the primary safety and efficacy endpoints in the ALIGN-AR trial.

The data was presented at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) Annual Scientific Symposium in San Francisco during 23-26 October. The data from the trial will support the premarket approval application with the US Food and Drug Administration (FDA).

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Aortic regurgitation occurs when there is reverse blood flow through the aortic valve due to inadequate closure of the aortic valve during diastole. The common symptoms of the disease include shortness of breath, chest pain and fatigue.

A market model by GlobalData forecasts the transcatheter aortic valve replacement market to be worth $19bn by 2033. The rise in popularity of these devices is partly attributed to faster recovery times.

The open-label single-arm investigation device exemption (IDE) ALIGN-AR trial (NCT04415047) evaluated the safety and efficacy of the Trilogy transcatheter heart valve system in 180 high-risk patients with symptomatic, severe aortic regurgitation.

The valve demonstrated effective orifice area (EOA), low transvalvular gradients, and low paravalvular regurgitation. Furthermore, left ventricular (LV) improvement was seen on echocardiography (ECG). The quality of life (QoL) and heart failure functional status showed improvement over one year.

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JenaValve received a CE mark for the Trilogy heart valve system for the treatment of both aortic regurgitation and aortic stenosis in May 2021.

The US-based company also has a strategic investment and exclusive technology licensing agreement with Peijia Medical Limited for the commercialisation of Trilogy valves in China. The agreement entitles JenaValve to milestone-based royalty payments along with additional capital.