Transcatheter valve replacement (TTVR) for the mitral and tricuspid valves is rapidly emerging as a promising new approach to treating heart valve disease. Following the success of TAVR for the aortic valve, attention is now shifting to these two crucial heart valves, which have traditionally been more challenging to treat with minimally invasive methods.

With Edwards Lifesciences and Medtronic leading the charge, innovative devices for both valves are now undergoing clinical trials. Recent milestones, such as Capstan Medical’s robotic-assisted valve replacements and Boston Scientific’s $175 million investment to support transcatheter mitral valve replacement, underscore the growing momentum in this field. As advancements continue, the potential for TTVR to transform heart valve therapy is becoming increasingly clear.

The Mechanics of Valve Disease

The heart is made up of four valves—aortic, pulmonary, mitral, and tricuspid—each playing a crucial role in keeping blood flowing in the right direction. These valves act like one-way gates, opening and closing with each heartbeat to ensure blood moves efficiently through the heart’s chambers and onward to the lungs and the rest of the body.

The mitral valve, located between the left atrium (upper left chamber) and left ventricle (lower left chamber), controls blood flow from the lungs into the heart before it’s pumped out to the rest of the body. The tricuspid valve, between the right atrium and right ventricle, manages blood flow from the body to the lungs for oxygenation (Figure 1). Because they regulate blood entering and exiting the heart’s main pumping chambers, these two valves are especially important to overall heart function.

Heart valves can be affected by several conditions that prevent them from working properly. The most common are regurgitation (a condition where the valve does not close properly, causing blood to flow backward) and stenosis (Figure 2). In regurgitation, the valve does not close completely, allowing blood to leak backward—much like a door that doesn’t fully shut. In stenosis, the valve becomes narrowed or stiff, restricting blood flow as if the gate were stuck. These issues can develop gradually and often lead to symptoms such as fatigue, shortness of breath, or swelling. If left untreated, they may eventually lead to heart failure.

Mitral and tricuspid valve regurgitation are relatively common, especially as people get older. Recent studies show that moderate-to-severe mitral regurgitation affects nearly 3 in 100 people by age 70, and more than 6 in 100 by age 90². Tricuspid regurgitation is also frequently seen in older adults, affecting about 4% of those over 75³.

For many years, the standard treatment for these diseases has been surgical repair or replacement, typically through open-heart surgery. Surgeons either repair the valve—reshaping or reinforcing it to restore function—or replace it entirely with a mechanical or bioprosthetic (tissue-based) valve. Edwards Lifesciences and Medtronic have been key players in developing these surgical techniques. Whenever possible, repair is generally preferred because it preserves the patient’s natural valve and can lead to better long-term outcomes.

However, in cases where repair is not possible, replacement becomes necessary. While both approaches are effective, they come with significant challenges—invasive surgery, extended recovery times, and risks related to general anesthesia and postoperative complications. These limitations have fueled growing interest in less invasive alternatives, particularly transcatheter valve replacement (TTVR). TTVR uses thin, flexible tubes (catheters) inserted through blood vessels—often from the groin—to access and treat the heart, offering a safer and quicker recovery for many patients compared to traditional open-heart surgery.

Expanding the Transcatheter Frontier Beyond the Aortic Valve

As interest in less invasive alternatives to open-heart surgery has grown, transcatheter techniques have revolutionized the treatment of heart valve disease—starting with the aortic valve. One of the most important breakthroughs was the development of Transcatheter Aortic Valve Replacement (TAVR), a procedure in which a diseased aortic valve is replaced using a catheter inserted through a blood vessel, typically via the groin or chest. This technique avoids open surgery altogether and significantly reduces recovery time and surgical risk, particularly for high-risk or elderly patients. Since its approval, TAVR has rapidly become the preferred treatment option for many aortic valve patients and has paved the way for applying similar methods to more complex valves—namely, the mitral and tricuspid valves.

Unlike the aortic valve, however, the mitral and tricuspid valves pose unique anatomical and technical challenges. Their irregular shapes, larger openings, and dynamic movement during the cardiac cycle make them harder to treat with catheter-based approaches. Despite these complexities, recent years have seen major advances in both transcatheter repair and replacement technologies for these valves—together referred to as Transcatheter Valve Repair and Replacement (TTVR).

2.1. Repair

The earliest successes in TTVR have been in valve repair, particularly for the mitral valve. Devices like the MitraClip, approved by the FDA in 2013, and the PASCAL system, which received FDA approval for mitral regurgitation in 2022 and CE Mark approval for both mitral (2022) and tricuspid (2020) regurgitation, have demonstrated that certain forms of valve dysfunction—especially regurgitation—can be treated effectively by reshaping or reinforcing the patient’s own valve rather than replacing it (Table 1).

MitraClip works by clipping the leaflets of the mitral valve together to reduce blood leakage, offering a minimally invasive alternative for patients who are not surgical candidates. PASCAL builds on this concept, with design enhancements that aim to improve ease of use and expand applicability to both mitral and tricuspid regurgitation. These repair systems are technically simpler to deliver compared to full valve replacements, as they preserve the existing valve structure and do not require precise sizing or anchoring of an artificial valve.

Table 1. Transcatheter repair technologies

2.2. Replacement

Despite the progress in repair, some patients—particularly those with severe disease or anatomy not suitable for repair—require full valve replacement. Here, the field is advancing rapidly, though challenges remain. Transcatheter valve replacement for the mitral and tricuspid valves involves entirely replacing the native valve with an artificial one delivered via catheter. This procedure is more complex due to valve size variability, anchoring difficulties, and the need to avoid interference with nearby heart structures.

Several companies are at the forefront of this innovation (Table 2):

• Abbott’s Tendyne Transcatheter Mitral Valve Implantation device has received CE Mark approval in Europe and is being studied in U.S. trials as a potential long-term solution for mitral valve disease
• Edwards Lifesciences has obtained both CE mark and FDA approval for it’s EVOQUE system, becoming the first transcatheter tricuspid technology to do so. In parallel, the company is developing transcatheter solutions for both the mitral valve, including ongoing trials using adaptations of its SAPIEN 3 valve technology.
• Medtronic’s Intrepid TMVR System is currently in pivotal clinical trials targeting patients with mitral regurgitation who are not eligible for surgery.

Table 2. Transcatheter replacement technologies*

While most of these technologies are still in clinical stages, they represent an important step toward offering curative solutions for patients with complex or inoperable valve conditions.

Market Dynamics: Betting on a Beating Heart

The transcatheter valve replacement (TTVR) market is quickly becoming one of the most dynamic segments in structural heart disease, with Medtronic, Edwards Lifesciences, Abbott, and Boston Scientific all making strategic moves to secure leadership positions. In August 2024, Edwards Lifesciences expanded its portfolio through the acquisition of JC Medical from Genesis MedTech, gaining rights to the J-Valve System for severe aortic regurgitation, alongside a $25 million equity investment aimed at supporting product and market development. Meanwhile, Boston Scientific, previously less prominent in this space, signaled its growing commitment with a $175 million investment to support transcatheter mitral valve replacement (TMVR) trials. In parallel, Capstan Medical made headlines by completing the world’s first robotic-assisted mitral and tricuspid valve replacements—an innovation that could redefine precision in structural heart procedures. Notably, in 2022, MicroPort® further reinforced its position by leading a Series C investment round to secure exclusive commercial rights to 4C Medical’s tricuspid products in China, highlighting the global scope and competitive intensity of the evolving TTVR landscape.

While these strategic investments underscore the rapid growth and innovation in the TTVR market, companies still face significant challenges related to regulatory approvals and reimbursement. In December 2024, the Centers for Medicare & Medicaid Services (CMS, the U.S. federal agency overseeing healthcare programs) proposed national coverage for transcatheter tricuspid valve replacement (TTVR), contingent upon participation in FDA-approved clinical trials. Similarly, in January 2021, CMS expanded coverage for transcatheter mitral valve repair, but these procedures remain tied to strict clinical guidelines, highlighting the importance of demonstrating long-term outcomes.

At the same time, healthcare infrastructure and capacity remain ongoing obstacles. In 2024, Edwards Lifesciences faced significant market challenges, including a $16 billion loss in market capitalization, partly driven by delays in hospital procedures due to capacity constraints³. As hospitals struggle to accommodate the growing demand for TAVR and TTVR procedures, manufacturers will need to address both logistical hurdles and the increasing need for specialized clinical training to meet these demands. With regulatory hurdles still in place and capacity issues continuing, the future success of TTVR technologies will depend on collaboration with healthcare providers, optimizing procedural efficiency, and ongoing clinical validation.

How can S&S help

The TTVR market is evolving rapidly, driven by technological advancements and increasing demand for minimally invasive solutions. Navigating this dynamic landscape requires a clear understanding of market trends, competitive forces, and emerging opportunities. At Sector & Segment, we can support you in achieving success in the TTVR space through our tailored approach to market research and strategic analysis:

• Developing growth strategies tailored to your company's objectives, leveraging our insights on distribution strategy, target market segmentation, and clinical evidence
• Tracking and mapping the competitive landscape and market’s evolution to provide up-to-date strategic guidance and accelerate market entry
• Assessing interest, feasibility, and potential barriers to adoption through direct engagement with interventional cardiologists worldwide
• Quantifying market potential through detailed market sizing and forecasting to help guide investment decisions and ensure alignment with your long-term business goals