The US Food and Drugs Administration (FDA) is expected to approve the JenaValve Trilogy System, a transcatheter aortic valve replacement (TAVR) device designed for aortic regurgitation (AR), by late 2025. This approval will mark a significant step forward, expanding TAVR’s treatment indications to include AR — a condition previously underserved by minimally invasive therapies. With its potential to improve clinical outcomes for a broader range of patients, the JenaValve Trilogy System underscores the growing adaptability of TAVR technology in treating complex heart conditions.

Since receiving approval for treating aortic stenosis (AS), the TAVR market has seen rapid growth, with a compound annual growth rate (CAGR) of 17% between 2015 and 2024. AR, however, has remained a largely underserved market, with limited treatment options for patients at high or prohibitive risk for traditional surgery. The JenaValve Trilogy System, specifically engineered to anchor securely in non-calcified valves — a hallmark of AR — has demonstrated a procedural success rate above 95% in recent trials, including the ALIGN-AR trial, highlighting its effectiveness in this challenging patient group.

The TAVR market is set to continue its growth trajectory, with the value of the market for AS alone projected to rise at a CAGR of 8% up to 2034. However, the addition of AR as a new indication is expected to drive a significant acceleration in growth, potentially pushing the CAGR into double digits. This trend is further supported by increasing demand for less-invasive therapies, particularly among ageing populations and patients with comorbidities who face higher risks with traditional surgical procedures.

A new chapter in structural heart therapy

The inclusion of AR as a new indication positions TAVR technology as a more comprehensive solution for heart valve diseases. As adoption of this technology expands, next-generation devices are expected to continue to enhance patient safety and procedural outcomes.

The expected approval of the JenaValve Trilogy System highlights a broader trend of innovation in structural heart care in which tailored, minimally invasive solutions are reshaping how complex cardiovascular conditions are treated. This approval marks the beginning of a new chapter in structural heart therapy - one that has the potential to transform patient outcomes and expand access to treatment for patients who were previously considered untreatable.