심혈관 수복 및 재건 기기 시장 : 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the cardiovascular repair and reconstruction devices market size is projected to be USD 5.03 billion in 2025, USD 5.37 billion in 2026, and reach USD 7.51 billion by 2031, growing at a CAGR of 6.92% from 2026 to 2031.

This report is Segmented by Product (Heart Valve Repair, Vascular Grafts, Patches, Annuloplasty, LAAC), Material (Biological, Synthetic, Metal, Bioabsorbable Hybrid), Application (CAD, Heart Valve Disease, Peripheral Vascular, Structural Heart), End User (Hospitals, Cath Labs, Ascs, Specialty Cardiac), and Geography (North America, Europe, and More). Forecast: Value (USD).

Global Cardiovascular Repair and Reconstruction Devices Market Trends and Insights

Rising Burden of Structural Heart and Vascular Disease

The cardiovascular repair and reconstruction devices market is benefiting from a disease base that remains large and still rising in absolute volume. Non-rheumatic valvular heart disease recorded 28.4 million prevalent cases globally in 2021, and global incidence is projected to reach 20.28 per 100,000 by 2035. TAVI volumes reached 150,000 procedures annually by 2021, yet the treatable valve population remains much larger, which shows that access limits, not disease absence, still hold back volumes in many emerging settings. As PCI and EP ablation capacity expands across Southeast Asia and Latin America, structural heart programs are likely to follow the same hospital adoption path already seen in other interventional services. The gap between rising case counts and lower age-standardized mortality rates shows that device-based intervention is taking on a growing share of incremental patient management, which directly supports long-run demand in the cardiovascular repair and reconstruction devices market.

Shift Toward Transcatheter and Minimally Invasive Repair

The cardiovascular repair and reconstruction devices market is also being lifted by a clear clinical shift toward transcatheter and minimally invasive repair. In a 12-year Japanese cohort, 30-day TAVI mortality fell from 2.8% in 2013 to 0.4% in 2024, while annual case volume increased fourfold over the same period. This improvement in outcomes has supported guideline expansion into lower-risk patient groups and has given regulators a stronger basis for approving newer systems. Abbott received FDA approval in May 2025 for the Tendyne TMVR system for severe mitral annular calcification, which opened a patient group that had very limited surgical or transcatheter options before that point. Edwards then received FDA approval in December 2025 for the SAPIEN M3 system as the first transseptal transcatheter mitral replacement therapy, showing that even difficult anatomical positions are moving toward percutaneous treatment. Germany also remains the highest-volume TAVI country in Europe, which indicates that established high-income systems are still generating new volume as indications widen.

High Capital Intensity of Advanced Valve and Graft Platforms

The cardiovascular repair and reconstruction devices market still faces a clear funding barrier because advanced valve systems and graft platforms remain expensive to procure and deploy. Per-implant costs for advanced transcatheter valves and next-generation graft technologies range from USD 25,000 to USD 50,000, which can limit adoption in cost-sensitive health systems. Boston Scientific's 2025 decision to discontinue global sales of Acurate neo2 and Acurate Prime after the platforms failed to secure FDA clearance shows how costly long development cycles can become, especially when clinical investment does not convert into commercial access. In middle-income markets, hospitals also need hybrid operating suites, advanced 3D imaging systems, and multidisciplinary structural heart teams, and these facility requirements often amount to USD 5 million or more. This cost structure strengthens the position of large manufacturers with broad portfolios and makes it harder for single-product entrants to disrupt the cardiovascular repair and reconstruction devices market.

Other drivers and restraints analyzed in the detailed report include:

1. Aging and Frailty-Driven Surgical Risk Profile
2. Imaging-Guided Device Navigation and Procedure Planning
3. Lengthy Regulatory Pathways for Class III Cardiovascular Devices

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Heart Valve Repair Devices held 36.31% of the cardiovascular repair and reconstruction devices market share in 2025, which made them the largest product category in the cardiovascular repair and reconstruction devices market. This position reflects strong procedure volumes across aortic stenosis, mitral regurgitation, and the developing tricuspid disease space. Edwards Lifesciences reported 97.9% freedom from structural valve deterioration and 97.8% freedom from reoperation due to structural valve deterioration at 10 years in the COMMENCE aortic trial for its RESILIA tissue bioprosthesis, which supports longer lifetime valve strategies and broader use in younger surgical patients. Left Atrial Appendage Closure Devices are the fastest-growing product type at 7.38% CAGR through 2031, supported by evidence that LAAC can act as a mechanical alternative to long-term anticoagulation in atrial fibrillation patients with high bleeding risk.

The OPTION trial published in 2024 showed LAAC was noninferior to oral anticoagulation after catheter ablation over 36 months and also delivered a lower rate of non-procedural major bleeding. Product innovation in LAAC is also accelerating, with Abbott reporting positive early VERITAS study results for Amulet 360 in February 2026 while Boston Scientific's WATCHMAN Elite IDE trial is expected to begin enrolling in 2026. This competitive build-out is likely to lift procedure volumes and place more pressure on pricing over time. Vascular Grafts, Cardiovascular Patches, and Annuloplasty Systems continue to serve complementary anatomical needs, and vascular grafts are drawing more attention as bioabsorbable conduit platforms move through EU pivotal development.

Biological Tissue captured 33.24% share in 2025, which kept it as the leading material base in the cardiovascular repair and reconstruction devices market. Its lead rests on long clinical use across surgical valve bioprostheses, pericardial patches, and tissue-engineered vascular constructs. The RESILIA bovine pericardial tissue platform has now shown 97.9% freedom from structural valve deterioration at 10 years, which sets a high durability threshold for competing biological formulations. Bioabsorbable and Hybrid Materials represent the fastest-growing material category, and this cardiovascular repair and reconstruction devices market size for the segment is projected to expand at 8.52% CAGR through 2031 because clinicians are showing stronger interest in implants that support native tissue regeneration before resorption.

Xeltis reported 12-month pivotal data for its aXess restorative vascular access conduit in 2026, showing 79% secondary patency and 60% fewer reinterventions than conventional ePTFE arteriovenous grafts. Preclinical and early clinical work on Xeltis' Xabg restorative coronary bypass conduit also points to future use in small-diameter bypass settings where no approved off-the-shelf option exists today. Synthetic Polymers and Metals and Alloys still remain essential in defined settings, with ePTFE and polyester serving peripheral bypass needs and nitinol or cobalt-chromium supporting self-expanding delivery frames. The shift toward hybrid and bioresorbable material systems is also visible in coronary scaffold research, where a PLLA and PLGA blend showed improved vessel healing versus conventional PLA platforms.

Complete Report Scope:

• By Product Type
  • Cardiovascular Repair Devices
  • Heart Valve Repair Devices
  • Vascular Grafts
  • Cardiovascular Patches
  • Annuloplasty Systems
  • Left Atrial Appendage Closure Devices
• By Material
  • Biological Tissue
  • Synthetic Polymers
  • Metals and Alloys
  • Bioabsorbable and Hybrid Materials
• By Application
  • Coronary Artery Disease
  • Heart Valve Disease
  • Peripheral Vascular Repair
  • Structural Heart Disease
• By End User
  • Hospitals
  • Cardiac Catheterization Laboratories
  • Ambulatory Surgical Centers
  • Specialty Cardiac Centers
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America accounted for 38.22% share of the cardiovascular repair and reconstruction devices market size in 2025, making it the leading regional block in the cardiovascular repair and reconstruction devices market. The United States anchors this position because it performs more than half of all TAVR implants globally and continues to post strong growth in transcatheter repair volumes. The region also remains the first launch market for major platforms, with Abbott's Tendyne TMVR approved in May 2025 and Edwards' SAPIEN M3 mitral replacement system approved in December 2025 in the United States. Europe holds the second-largest position, and Germany performs the highest TAVI volumes on the continent. Under EU MDR, and with joint clinical assessments starting in 2026, commercialization timelines for novel structural implants are lengthening compared with the earlier framework, which is a larger burden for smaller innovators.

Asia-Pacific is the fastest-growing region at 7.65% CAGR over 2026-2031, and the cardiovascular repair and reconstruction devices market there is gaining from rising structural disease incidence, broader interventional infrastructure, and approvals for newer device classes. South Korea and Australia serve as important adoption anchors because both have established interventional cardiology networks and reimbursement structures that support technology uptake. India is also gaining procedural momentum as newer TAVR delivery systems reach local centers and broaden physician familiarity with advanced valve therapy. The regional opportunity remains large because procedure penetration still trails the underlying disease base in many Asia-Pacific countries.

South America and the Middle East and Africa contribute smaller shares to the cardiovascular repair and reconstruction devices market, but both regions offer meaningful long-term room for expansion. Brazil leads South American demand through its concentration of cardiac surgery hospitals and established TAVI programs. Argentina adds procedure volume through its private healthcare system, especially for higher-complexity structural interventions. In the Middle East, GCC countries are expanding catheterization capacity to reduce outbound medical travel, and UAE programs are handling more cases and greater complexity. South Africa remains the anchor in sub-Saharan Africa because it records the highest structural heart procedural volumes on the continent. Device pricing remains a barrier in both regions, which keeps adoption tied to hybrid procurement models and slows growth relative to Asia-Pacific or North America. Manufacturers are therefore leaning more on tiered portfolios and health-economics arguments to gain formulary access in constrained purchasing environments.

1. Abbott Laboratories
2. Artivion, Inc.
3. AtriCure
4. Beckton Dickinson
5. BIOTRONIK
6. Boston Scientific
7. Cardiac Dimensions, Inc.
8. Cook Group
9. Corcym S.r.l.
10. Edward Lifesciences
11. Getinge
12. Jenavalve Technology
13. LeMaitre Vascular
14. LivaNova
15. Medtronic
16. MicroPort
17. Neovasc Inc.
18. Teleflex
19. Terumo
20. W. L. Gore and Associates, Inc.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Burden of Structural Heart and Vascular Disease
  • 4.2.2 Shift Toward Transcatheter and Minimally Invasive Repair
  • 4.2.3 Aging and Frailty-Driven Surgical Risk Profile
  • 4.2.4 Imaging-Guided Device Navigation and Procedure Planning
  • 4.2.5 Hospital Ambulatory Migration for Selected Cardiac Interventions
  • 4.2.6 Demand for Durable, Reintervention-Reducing Implants
• 4.3 Market Restraints
  • 4.3.1 High Capital Intensity of Advanced Valve and Graft Platforms
  • 4.3.2 Lengthy Regulatory Pathways for Class III Cardiovascular Devices
  • 4.3.3 Reimbursement Friction for Newer Structural Heart Technologies
  • 4.3.4 Long-Term Evidence Requirements for Implant Durability and Patency
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Product Type
  • 5.1.1 Cardiovascular Repair Devices
  • 5.1.2 Heart Valve Repair Devices
  • 5.1.3 Vascular Grafts
  • 5.1.4 Cardiovascular Patches
  • 5.1.5 Annuloplasty Systems
  • 5.1.6 Left Atrial Appendage Closure Devices
• 5.2 By Material
  • 5.2.1 Biological Tissue
  • 5.2.2 Synthetic Polymers
  • 5.2.3 Metals and Alloys
  • 5.2.4 Bioabsorbable and Hybrid Materials
• 5.3 By Application
  • 5.3.1 Coronary Artery Disease
  • 5.3.2 Heart Valve Disease
  • 5.3.3 Peripheral Vascular Repair
  • 5.3.4 Structural Heart Disease
• 5.4 By End User
  • 5.4.1 Hospitals
  • 5.4.2 Cardiac Catheterization Laboratories
  • 5.4.3 Ambulatory Surgical Centers
  • 5.4.4 Specialty Cardiac Centers
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
  • 6.3.1 Abbott Laboratories
  • 6.3.2 Artivion, Inc.
  • 6.3.3 AtriCure, Inc.
  • 6.3.4 Becton, Dickinson and Company
  • 6.3.5 Biotronik SE and Co. KG
  • 6.3.6 Boston Scientific Corporation
  • 6.3.7 Cardiac Dimensions, Inc.
  • 6.3.8 Cook Medical LLC
  • 6.3.9 Corcym S.r.l.
  • 6.3.10 Edwards Lifesciences Corporation
  • 6.3.11 Getinge AB
  • 6.3.12 JenaValve Technology, Inc.
  • 6.3.13 LeMaitre Vascular, Inc.
  • 6.3.14 LivaNova PLC
  • 6.3.15 Medtronic plc
  • 6.3.16 MicroPort Scientific Corporation
  • 6.3.17 Neovasc Inc.
  • 6.3.18 Teleflex Incorporated
  • 6.3.19 Terumo Corporation
  • 6.3.20 W. L. Gore and Associates, Inc.

7 Market Opportunities & Future Outlook

• 7.1 White-Space and Unmet-Need Assessment