Structural Heart Devices Market Trends, Size and Growth Forecast to 2034

The global Structural Heart Devices Market reached a valuation of USD 13.84 billion in 2024 and is forecast to hit USD 35.96 billion by 2034, growing at a compound annual growth rate (CAGR) of 10.2% during 2025-2034.

Structural heart devices are used in the repair or replacement of cardiac structures without open-heart surgery. These include devices for valve replacement, septal defect closure, and appendage occlusion. Transcatheter solutions are particularly gaining favor due to their reduced surgical risks and quicker recovery times.

Download Full PDF Sample Copy of Market Report @
https://exactitudeconsultancy.com/request-sample/67016

Key Market Drivers
• Rise in Geriatric Population: Aging patients are more susceptible to valvular diseases such as aortic stenosis and mitral regurgitation-driving demand for TAVR and TMVR.
• Minimally Invasive Procedure Adoption: Surgeons and patients alike prefer transcatheter techniques that avoid sternotomy and prolonged hospitalization.
• Increased Diagnostic Accuracy: Advancements in echocardiography and cardiac CT have improved early detection of structural defects.
• Clinical Trials Supporting Efficacy: Multinational trials continue to validate long-term safety and effectiveness of transcatheter approaches in moderate-risk and younger patients.
• Government and Insurance Support: Coverage for TAVR, LAAO, and TMVR under national health insurance is expanding in developed and emerging markets.

Key Restraints and Challenges
• High Cost of Structural Heart Procedures: TAVR and other transcatheter interventions are significantly costlier than traditional therapies in some regions.
• Complex Regulatory Approval Process: Devices for structural interventions require rigorous testing and post-market surveillance, delaying time-to-market.
• Limited Trained Workforce: Skilled cardiologists trained in structural interventions are still concentrated in urban and high-income regions.
• Device Failures and Recall Risks: Valve leakage, migration, or device fracture can lead to critical outcomes and liability for manufacturers.
• Access Gaps in Developing Countries: Infrastructure and reimbursement challenges in many countries limit the reach of structural heart therapies.

Get Your Exclusive Offer with up to 10% Discount : https://exactitudeconsultancy.com/checkout/?currency=USD&type=single_user_license&report_id=67016

Opportunities & Trends
• Expansion of TAVR in Low- and Moderate-Risk Populations: Initially approved for high-risk patients, TAVR is now being offered to younger and lower-risk segments.
• Next-Generation Valve Designs: Companies are introducing valves with better hemodynamics, lower thrombosis risks, and longer durability.
• Transcatheter Mitral Valve Replacement (TMVR): A fast-growing area addressing the complex mitral anatomy through innovative repair and replacement systems.
• Left Atrial Appendage Closure Devices (LAAO): Demand is rising as alternatives to long-term anticoagulants in atrial fibrillation patients.
• Hybrid Operating Rooms and Robotics: Integration of robotic and image-guided systems enhances procedural safety and precision.

Market Segmentation
By Product Type
• Heart Valve Devices
o Transcatheter Aortic Valve Replacement (TAVR)
o Transcatheter Mitral Valve Repair/Replacement (TMVR)
o Surgical Valves
• Occluders and Closure Devices
o Atrial Septal Defect (ASD) Closure Devices
o Ventricular Septal Defect (VSD) Closure Devices
o Patent Foramen Ovale (PFO) Closure Devices
• Annuloplasty Rings
• Left Atrial Appendage Closure (LAAO) Devices
• Other Structural Repair Devices

By Procedure
• Repair Procedures
o Annuloplasty
o LAA Closure
o Septal Defect Closure
• Replacement Procedures
o Aortic Valve
o Mitral Valve
o Tricuspid Valve

By End User
• Hospitals
• Cardiac Specialty Centers
• Ambulatory Surgical Centers
• Academic and Research Institutions

Regional Insights
North America
North America leads the global market due to strong penetration of TAVR and LAAO, wide availability of trained specialists, and support from Medicare and private payers. The U.S. is the innovation hub for structural heart clinical trials.
Europe
Europe is driven by high-volume structural interventions in Germany, France, and the UK, supported by public health infrastructure and favorable regulatory frameworks. CE mark approvals also allow faster rollouts than in the U.S.
Asia-Pacific
This region is witnessing exponential growth with increased investments in heart care infrastructure. Countries like China and India are seeing double-digit growth in cath lab installations and transcatheter procedures.

Explore Full Report here: https://exactitudeconsultancy.com/reports/67016/structural-heart-devices-market

Competitive Landscape
The market is highly consolidated, with major players investing heavily in R&D, clinical trials, and cross-border acquisitions to expand product offerings in structural heart therapies.
Key Players
• Medtronic: Offers CoreValve EvolutTM, IntrepidTM TMVR, and LAAO devices; leader in transcatheter valve therapies.
• Edwards Lifesciences: Pioneer of SapienTM valve series; strong portfolio in mitral and tricuspid valve replacement.
• Abbott: Manufacturer of MitraClipTM, AmplatzerTM Occluders, and TriClipTM for transcatheter repair therapies.
• Boston Scientific: Offers Watchman FLXTM for LAA closure and Lotus EdgeTM valve (recently discontinued but under review for relaunch).
• LivaNova: Focused on surgical valve repair and congenital heart defect devices; presence in pediatric cardiac markets.
• CryoLife (now part of Artivion): Known for BioGlue, On-X mechanical valves, and aortic repair solutions.
• Lepu Medical: Rapidly expanding its transcatheter valve and occluder device line in the Asia-Pacific region.
• Braile Biomedica: Leading Latin American valve manufacturer with expanding export footprint.
• JenaValve: Developer of transapical and transfemoral valves for high-risk aortic patients.
• Micro Interventional Devices: Innovator in sutureless annuloplasty and less-invasive structural heart tools.

Recent Developments (2025)
1. July 2025 - Medtronic Receives FDA Approval for Evolut FX+
Medtronic launched Evolut FX+, featuring improved delivery accuracy and adaptive sealing for low-risk aortic stenosis patients in the U.S.
2. June 2025 - Edwards Lifesciences Begins Trial for Sapien M3 TMVR
Edwards initiated global trials for Sapien M3, its first transseptal mitral valve replacement system with self-expanding frame and rapid deployment.
3. May 2025 - Abbott's TriClip Gains CE Mark for Tricuspid Regurgitation
Abbott's TriClip G4 was approved in Europe for minimally invasive repair of tricuspid regurgitation, expanding its transcatheter repair offerings.
4. April 2025 - Boston Scientific Expands Watchman FLX to Japan
Boston Scientific entered the Japanese market with its Watchman FLX for LAA closure, targeting the growing atrial fibrillation segment.
5. March 2025 - Lepu Medical Signs Strategic Deal with Indian Hospitals
Lepu announced distribution partnerships with top Indian cardiac centers to supply ASD and VSD occluders and begin clinical trials for TAVR valves.

Events and Implications
• TAVR Supplants Surgical Valve Replacement in High-Income Countries: Clinical data continues to support equal or superior outcomes in many patient subsets.
• TMVR Expected to Boom by 2030: Addressing an unmet need in severe mitral regurgitation with fewer procedural complications than surgery.
• LAAO Devices Competing with Anticoagulants: Watchman and Amplatzer devices are becoming standard in stroke prevention among AF patients with bleeding risks.
• Device Bundling in Hybrid ORs: Cardiologists and surgeons are collaborating to perform complex multi-defect repairs in a single session.
• Focus on Pediatric and Congenital Interventions: ASD, VSD, and PFO closure devices are being designed for better adaptability in children and young adults.

Conclusion
The Structural Heart Devices Market is entering a golden era of innovation and expansion, fueled by clinical advancements, regulatory support, and patient demand for minimally invasive care. With double-digit growth expected in transcatheter procedures and expanding application in emerging economies, the next decade will see a dramatic rise in structural interventions.
From TAVR and TMVR to occluders and LAAO systems, these devices are transforming cardiovascular treatment paradigms, offering new hope to millions of patients with life-threatening conditions-without the need for open-heart surgery.

This report is also available in the following languages : Japanese (構造的心臓デバイス市場), Korean (구조적 심장 장치 시장), Chinese (结构性心脏设备市场), French (Marché des dispositifs cardiaques structurels), German (Markt für strukturelle Herzgeräte), and Italian (Mercato dei dispositivi cardiaci strutturali), etc.

Request for a sample of this research report at (Use Corporate Mail ID for Quick Response) @ https://exactitudeconsultancy.com/reports/67016/structural-heart-devices-market#request-a-sample

Our More Reports:

Spin-Transfer Torque Random Access Memory Market
https://exactitudeconsultancy.com/reports/62914/global-spin-transfer-torque-random-access-memory-market

Complex Programmable Logic Devices (CPLD) Market
https://exactitudeconsultancy.com/reports/62916/global-complex-programmable-logic-devices-cpld-market

Fibre-Optic Gyroscope Market
https://exactitudeconsultancy.com/reports/62928/global-fibre-optic-gyroscope-market

About Us
Exactitude Consultancy is a market research & consulting services firm which helps its client to address their most pressing strategic and business challenges. Our market research helps clients to address critical business challenges and also helps make optimized business decisions with our fact-based research insights, market intelligence, and accurate data.
https://bulletin.exactitudeconsultancy.com/

https://www.thehealthanalytics.com/

https://www.analytica.global/

https://www.marketintelligencedata.com/

https://www.marketinsightsreports.com/

https://exactitudeconsultancy.com/

Connect Us:
Irfan Tamboli
PHONE NUMBER +1 (704) 266-3234
EMAIL ADDRESS: sales@exactitudeconsultancy.com

This release was published on openPR.