Analysts predict that the JenaValve Trilogy System, a transcatheter aortic valve replacement (TAVR) device, is on track to receive FDA approval by late 2025 for the treatment of aortic regurgitation (AR). This approval would mark a significant expansion of TAVR technology, which is currently used to treat aortic stenosis (AS), to include a patient population with AR who have limited treatment options.
The JenaValve Trilogy System is specifically designed to address the challenges of AR, a condition characterized by the leakage of blood backward through the aortic valve. Unlike AS, where the valve is narrowed and often calcified, AR typically involves a non-calcified valve, requiring a device that can securely anchor in this environment. The JenaValve system has demonstrated a procedural success rate exceeding 95% in recent clinical trials, including the ALIGN-AR trial, highlighting its effectiveness in treating this challenging patient group.
The ALIGN-AR trial, which evaluated patients with severe, symptomatic AR at high risk for surgery, showed promising results. Two-year follow-up data revealed that the all-cause mortality rate remained below the study's predefined performance goal of 25% at one year. The data also included excellent hemodynamic outcomes, low rates of paravalvular leak, and sustained improvements in quality of life.
GlobalData analysts emphasize the potential impact of this approval, stating that the JenaValve Trilogy System underscores the growing adaptability of TAVR technology in treating complex heart conditions. The expansion of TAVR to include AR is expected to drive significant growth in the structural heart market, potentially pushing the compound annual growth rate (CAGR) into double digits. This growth is further supported by the increasing demand for less-invasive therapies, particularly among aging populations and patients with comorbidities who face higher risks with traditional surgical procedures.
Edwards Lifesciences, a leader in the TAVR market with its Sapien valves, agreed to acquire JenaValve as part of a $1.2 billion deal. This acquisition positions Edwards to capitalize on the expected growth in the AR treatment market. The JenaValve Trilogy System is already commercially available in Europe under CE mark for the treatment of symptomatic AR.
The anticipated FDA approval of the JenaValve Trilogy System represents a significant advancement in structural heart therapy, offering a less-invasive treatment option for patients with AR who were previously considered untreatable. This development has the potential to transform patient outcomes and expand access to care for this underserved population.
