Press release
Structural Heart Devices Market is set for steady growth to US$ 28.84 billion by 2033, led by North America 52.5% of global market share.
Structural Heart Devices Market
Market growth is driven by the rising prevalence of structural heart diseases, including valvular disorders and congenital heart defects, along with the growing geriatric population worldwide. Increasing adoption of minimally invasive and transcatheter procedures such as TAVR and MitraClip, advancements in device design and imaging technologies, and expanding clinical evidence supporting improved patient outcomes are further supporting market expansion. Additionally, improving healthcare infrastructure, physician expertise, and favorable reimbursement policies are accelerating adoption of structural heart devices.
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United States: Key Industry Developments
✅ December 2025: Edwards Lifesciences received FDA approval for an upgraded SAPIEN 3 Ultra RESILIA valve system in structural heart repair, featuring enhanced durability and reduced paravalvular leak rates by 20% for high-risk TAVR patients.
✅ October 2025: Medtronic expanded its Evolut FX+ platform with next-gen self-expanding transcatheter valves, improving deployment precision and hemodynamic performance in complex aortic stenosis cases across U.S. centers.
✅ August 2025: Boston Scientific launched the WATCHMAN FLX Pro left atrial appendage closure device iteration, boosting seal efficiency and reducing procedural complications amid rising AFib-related stroke prevention needs.
Asia Pacific / Japan: Key Industry Developments
✅ November 2025: Terumo Corporation introduced its Aortic Valve Transcatheter System in Japan, enabling minimally invasive TAVR procedures with improved radial force control for native valve anatomy adaptations.
✅ September 2025: Abbott secured Japanese PMDA approval for the next-gen MitraClip G4+ system, enhancing clip repositionability and grasp force for severe mitral regurgitation treatment in aging populations.
✅ July 2025: Medtronic partnered with Japanese firms to roll out the CoreValve Evolut PRO+ in local markets, focusing on supra-annular valve design for better flow dynamics in structural heart interventions
Recent M&A Activity:-
Affluent Medical - Caranx Medical and Artedrone : Affluent Medical solidified its position in the structural heart devices market by acquiring Caranx Medical and Artedrone on December 18, 2025, forming the new entity Carvolix focused on pioneering cardiovascular therapies including cardiac valve replacement technologies, enhancing its pipeline for transcatheter interventions and stroke prevention devices amid growing demand for minimally invasive structural heart solutions.
Boston Scientific - Bolt Medical : Boston Scientific strengthened its cardiovascular portfolio with the acquisition of Bolt Medical announced on January 8, 2025, for up to $664 million, incorporating an advanced laser-based intravascular lithotripsy platform that supports structural heart procedures by enabling effective calcium modification in coronary and peripheral vessels, positioning the company to launch innovative IVL systems in 2026.
Integer Holdings - Precision Coating : Integer Holdings boosted its capabilities in cardiovascular device manufacturing through the acquisition of Precision Coating in February 2025, integrating advanced surface treatments essential for structural heart devices like valves and repair systems, improving durability and performance to meet rising procedural volumes in transcatheter heart interventions.
Market Segmentation Analysis:
Repair Devices
Repair devices, including occluders, annuloplasty devices, valvuloplasty devices, and others, represent a significant portion of the structural heart market, often holding around 40-45% share in recent years due to rising minimally invasive repair procedures. Occluders lead within this category for closing septal defects, driven by high procedural volumes for atrial conditions.
Replacement Devices
Replacement devices dominate with mechanical valves, bioprosthetic valves, and TAVR commanding over 50% market share in 2026, particularly valve replacement procedures at 53.1%. TAVR specifically holds the largest revenue share owing to its adoption in aortic stenosis treatment among elderly patients.
Applications
Atrial septal defect and aortic valve stenosis are primary applications, with heart valve diseases overall capturing 75.5% share in 2025. Mitral regurgitation and ventricular septal defects follow, fueled by increasing prevalence of structural abnormalities requiring targeted interventions.
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Growth Drivers:-
Rising prevalence of cardiovascular and valvular heart diseases due to aging populations
Increasing adoption of minimally invasive and transcatheter cardiac procedures
Technological advancements in structural heart devices improving safety and outcomes
Growing demand for early diagnosis and timely intervention of heart defects
Expanding geriatric population with higher risk of structural heart conditions
Improved healthcare infrastructure and access to advanced cardiac care
Favorable reimbursement policies and increasing healthcare expenditure in developed regions
Regional Insights:
North America commands the largest share of the Structural Heart Devices Market, estimated at around 52.5% in recent assessments, driven by advanced healthcare infrastructure, high prevalence of cardiovascular diseases, widespread adoption of transcatheter procedures like TAVR, and favorable reimbursement policies in the US.
Europe follows as the second-largest region, benefiting from stringent medical device regulations, rising procedural volumes in countries like Germany, France, and the UK, and growing adoption of minimally invasive structural heart interventions amid steady market expansion.
Asia Pacific ranks third in market share, yet exhibits the fastest growth potential with elevated CAGRs in nations such as China, India, and Japan, fueled by healthcare infrastructure improvements, increasing cardiovascular burden, government investments, and expanding access to advanced cardiac technologies.
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Key Players:
The major global players in the global structural heart devices market include Medtronic, Abbott, JenaValve, Artivion, Inc., Boston Scientific Corporation, Micro Interventional Devices, Biomerics, TORAY INDUSTRIES, INC., Occlutech LLC, Shanghai MicroPort Medical (Group) Co.Ltd. among others.
Emerging Players
Capstan Medical, Vesalius Cardiovascula, and Orchestra BioMed among others.
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