
Edwards Life Sciences Announces CE Mark of First Transcatheter Tricuspid Valve; TRISCEND II Data Expected in June 2024 and U.S. Approval by End of 2024
Edwards Lifesciences has announced that its EVOQUE tricuspid valve replacement system has been granted the CE Mark for the transcatheter treatment of patients with tricuspid regurgitation (TR). This marks the world’s first transcatheter valve replacement therapy approved for treating TR. Previous valve replacement devices have required surgical intervention.
Tricuspid valve regurgitation is a medical condition characterized by the backward leakage of blood through the tricuspid valve each time the right ventricle contracts. This regurgitation happens as the right ventricle works to pump blood forward to the lungs, allowing some blood to flow in the reverse direction, back into the right atrium. This reverse flow increases the volume of blood within the atrium and can result in the enlargement of the right atrium. This, in turn, can impact the pressure in adjacent chambers and blood vessels. The primary cause of tricuspid regurgitation is often an enlarged lower heart chamber, specifically the right ventricle. However, other underlying conditions can also lead to tricuspid regurgitation, including infective endocarditis (valve infection), less commonly, conditions like Marfan syndrome, rheumatoid arthritis, rheumatic fever, injury, carcinoid tumors, and myxomatous degeneration. In terms of symptoms, tricuspid valve regurgitation may not always present obvious signs, and the symptoms that do occur can be quite vague, such as generalized weakness and fatigue. These symptoms arise because the heart struggles to pump sufficient blood to provide the body with the required oxygen. Additional symptoms that may be linked to tricuspid regurgitation include the pulsing of neck veins, an enlarged liver, abdominal swelling, and swelling in the legs, ankles, and/or feet. The severity of symptoms can vary depending on the extent of the regurgitation and its impact on the overall function of the heart. Tricuspid valve regurgitation is believed to impact approximately 1.6 million individuals in the U.S. and 3 million in Europe. The current global market for tricuspid valve repair was estimated at $640 million in 2022.
Daveen Chopra, Edwards’ corporate vice president of transcatheter mitral and tricuspid therapies, expressed the company’s commitment to addressing unmet patient needs through innovation. The CE Mark approval enables Edwards to offer a broader range of treatment options for eligible tricuspid disease patients throughout Europe. The EVOQUE system encompasses a nitinol self-expanding frame, intra-annular sealing skirt, and tissue leaflets crafted from the same bovine pericardial tissue used in the company’s renowned heart valves. This transcatheter tricuspid valve replacement system will be available in three sizes, all delivered through a low-profile transfemoral 28F system.
The approval follows on year results from the TRISCEND study were presented at the PCR London Valves 2022 event, revealing favorable safety and effectiveness outcomes, as well as significant improvements in quality of life. These findings included high survival rates (90.1%) and freedom from heart failure hospitalization (88.4%). The study demonstrated substantial reduction of TR to mild or trace TR (97.6%) and enhancements in functional and quality-of-life outcomes (93% of patients in NYHA Class I or II, compared to 26% at baseline, along with a 26-point increase in KCCQ score over baseline). Further insights into the EVOQUE system’s performance will be presented during the 35th Transcatheter Cardiovascular Therapeutics (TCT) symposium in San Francisco in late October.
In the U.S. Edwards Life Science is currently running the TRISCEND II pivotal trial with anticipated primary completion in mid-2024. The study is a prospective, multi-center, and randomized controlled pivotal clinical trial to assess the safety and effectiveness of the EVOQUE System when combined with optimal medical therapy (OMT), as compared to OMT alone. The trial focuses on treating patients who have been diagnosed with at least severe tricuspid regurgitation. The company anticipates U.S. approval in late 2024.