United States Transcatheter Tricuspid Valve Intervention (TTVI) Market 2031 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

Transcatheter tricuspid valve intervention (TTVI) market is growing at a high CAGR during the forecast period (2023-2030).

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Key Development:

United States: Recent Industry Developments

✅ In December 2025, the U.S. FDA approved initiation of the TRICAV II pivotal trial evaluating the TricValve® Transcatheter Bicaval Valve System to treat severe tricuspid regurgitation, advancing clinical development of a minimally invasive option for patients with limited surgical choices and severe symptoms.

✅ In November 2025, the Johns Hopkins Structural Heart team performed a new commercially approved transcatheter tricuspid valve replacement (TTVR) procedure using the Evoque system, highlighting broader clinical adoption of FDA‐cleared TTVR technology for high‐risk patients.

✅ In October 2025, Laplace Interventional completed enrollment in its U.S. Early Feasibility Study (EFS) of a trans‐jugular transcatheter tricuspid valve replacement (TTVR) system and added a trans‐femoral approach, marking progress in next‐generation device development.

✅ In October 2025, Venus Medtech's Cardiovalve completed enrollment in the TARGET study with 150 patients, advancing toward CE mark submission for its transcatheter tricuspid valve replacement system following successful interim safety and performance results

✅ In March 2025, the U.S. Centers for Medicare & Medicaid Services (CMS) finalized national coverage for TTVR procedures under a Coverage with Evidence Development (CED) pathway when used for FDA‐approved indications, improving access for eligible patients.

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Japan: Recent Industry Developments

✅ In July 2025, Abbott Medical Japan received regulatory approval for the TriClipTM transcatheter edge‐to‐edge repair system, the first tricuspid valve repair device formally cleared in Japan, offering a new minimally invasive option for patients with severe tricuspid regurgitation.

✅ In late 2025, clinical discussions and academic focus on expanding tricuspid transcatheter therapies across the Asia‐Pacific region underscored ongoing innovation and interest in minimally invasive structural heart interventions.

✅ In mid‐2025, TRISCEND JAPAN study enrollment continued to assess safety/effectiveness of an Edwards transcatheter tricuspid valve system, supporting evidence generation toward future regulatory milestones.

✅ In 2025, transcatheter tricuspid interventions including TriClip and other repair/replacement devices continued investigational use in Japan as part of ongoing clinical development and early feasibility evaluations, aligning with emerging regional application trends.

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Key Players:

=> Edwards Lifesciences, Abbott Laboratories, Medtronic, Venus MedTech, Navigate Cardiac Structures, Inc., CroíValve and Cardiovalve.

Key Segments:

By Intervention Type

Tricuspid Valve Repair (TVr) leads with 55% share, driven by preference for minimally invasive procedures, reduced complications, and improved patient outcomes. Tricuspid Valve Replacement (TVR) accounts for 45%, supported by cases where repair is not feasible and growing adoption of prosthetic and transcatheter replacement solutions.

By Disease Type

Tricuspid Regurgitation (TR) dominates with 65% share, fueled by high prevalence of valve leakage, increasing diagnostic awareness, and intervention demand for chronic heart disease patients. Tricuspid Stenosis (TS) holds 35%, driven by structural valve narrowing cases and targeted intervention strategies in hospitals and specialized cardiac centers.

By End-User

Hospitals lead with 60% share, supported by advanced cardiac care facilities, access to surgical expertise, and high patient volumes. Ambulatory Surgical Centers account for 25%, driven by outpatient interventions, minimally invasive procedures, and growing patient preference for reduced hospital stays. Other end-users hold 15%, including specialized cardiac clinics and research institutes performing clinical trials and advanced interventions.

By Region

North America - 35% Share
North America leads with 35%, driven by high prevalence of tricuspid valve disorders, advanced cardiac care infrastructure, and increasing adoption of minimally invasive repair and replacement procedures in the U.S. and Canada.

Europe - 30% Share
Europe holds 30%, supported by well-established hospitals, increasing awareness of valve diseases, and adoption of transcatheter interventions in Germany, France, U.K., Italy, Spain, and neighboring countries.

Asia Pacific - 25% Share
Asia Pacific accounts for 25%, fueled by rising cardiovascular disease prevalence, expanding hospital infrastructure, and growing adoption of advanced cardiac procedures in China, India, Japan, and Southeast Asia.

Middle East & Africa - 6% Share
The Middle East & Africa represent 6%, supported by specialized cardiac centers, healthcare modernization, and growing access to surgical interventions in GCC countries, South Africa, and other regions.

Latin America - 4% Share
Latin America holds 4%, driven by hospital investments, cardiac care adoption, and rising awareness of valve disease treatment in Brazil, Mexico, and neighboring countries.

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