심장외과수술 기기 시장 규모, 점유율, 동향 분석(2025-2032년)

Global Cardiac Surgery Device Market Report

The global cardiac surgery device market was valued at $21.1 billion in 2025. It is expected to grow at a compound annual growth rate (CAGR) of 5.5%, reaching $30.8 billion by 2032.

This report covers the global market for cardiac surgery devices, including heart valves, structural heart devices, coronary artery bypass products, circulatory support devices, closure devices, preshaped guidewires, and extracorporeal membrane oxygenation (ECMO) products.

The analysis includes unit sales, average selling prices (ASPs), procedure numbers, market size, market shares, growth trends, market forecasts through 2032, and historical data back to 2022.

Market growth is supported by rising device prices, increasing adoption of transcatheter tricuspid valve repair, and continued expansion of transcatheter aortic valve implantation. However, anticoagulant requirements, ONCAB-related side effects, and alternative treatments in competing markets continue to limit stronger growth.

Market Overview

The global cardiac surgery device market includes a broad range of devices used to treat structural heart disease, valvular disease, coronary artery disease, heart failure, congenital defects, and severe cardiopulmonary conditions.

The market includes traditional surgical devices, transcatheter repair and replacement technologies, mechanical circulatory support systems, closure devices, bypass-related products, and ECMO systems. This wide product scope reflects the complexity of modern cardiac care.

Ongoing advancements in cardiac diagnostic technologies are helping expand the diagnosed patient population. Improvements in computed tomography and magnetic resonance imaging have made it easier to identify structural heart and valvular disease earlier and more accurately.

Historically, many patients with valve disorders were diagnosed only after symptoms appeared and disease had progressed. Broader use of advanced imaging and routine cardiovascular evaluations is now supporting earlier detection, increasing referrals for surgical and transcatheter interventions, and contributing to sustained demand for cardiac surgery devices globally.

Market Drivers

Rising Device Prices

Global inflation is driving price increases across much of the cardiac surgery device market. Although inflation is expected to slow over the forecast period, average device prices are still expected to increase.

This trend supports market value growth across many cardiac surgery segments, especially those involving advanced implants, transcatheter systems, and complex device platforms.

However, the impact of rising prices varies by market. In some regions and product categories, competitive pricing between companies moderates ASP growth. Even so, higher device prices remain an important contributor to overall market expansion.

Transcatheter Tricuspid Valve Repair

Transcatheter tricuspid valve repair is becoming an important growth driver within the cardiac surgery device market. Tricuspid regurgitation represents a large and historically underserved patient population, especially among elderly individuals and patients with heart failure.

Despite its clinical importance, tricuspid regurgitation has traditionally been underdiagnosed and undertreated. Increasing clinical awareness, better imaging, and improved screening practices are helping physicians identify clinically significant disease earlier.

Transcatheter tricuspid valve repair procedures avoid sternotomy and cardiopulmonary bypass, making them attractive for higher-risk patients. This aligns with the broader shift toward minimally invasive cardiovascular care and is expected to support growing adoption of transcatheter treatment options.

Transcatheter Aortic Valve Implantation

The global transcatheter aortic valve implantation market is expected to grow strongly over the forecast period. This growth is supported by the large patient population requiring treatment for aortic valve disease.

TAVI has become a major part of structural heart care because it provides a less invasive alternative to surgical aortic valve replacement for many patients. As eligibility expands and clinical experience increases, procedure volumes are expected to continue rising.

The market is also supported by improved imaging, earlier diagnosis, and broader referral pathways for patients with aortic stenosis. These factors are expected to keep TAVI one of the most important growth areas within the global cardiac surgery device market.

Market Limiters

Anticoagulants

The need for anticoagulants remains a major limiter for mechanical heart valves and other metal implants. Patients with these implants require consistent anticoagulation therapy because clots can form due to red blood cell and platelet damage.

These clots can block blood vessels and lead to serious complications or death. As a result, patients who receive mechanical heart valves require lifelong anticoagulant therapy, such as warfarin, along with regular blood testing for safety.

Anticoagulants can also create risks if the patient experiences bleeding, since they inhibit clot formation. Tissue heart valves and other biocompatible implants do not require the same level of anticoagulant use because they provide better blood flow dynamics and cause less clot formation. Until a biocompatible polymer can match the durability of mechanical valves while reducing clot formation, anticoagulant requirements will continue to limit growth.

ONCAB Negative Side Effects

On-pump coronary artery bypass procedures require use of a cardiopulmonary bypass pump. This exposes patient blood to foreign surfaces and has been linked to higher risk of bleeding and short-term neurocognitive effects.

These effects are often described as post-perfusion syndrome, or "pump head." Symptoms can include issues with attention, concentration, short-term memory, fine motor function, and the speed of mental and motor responses.

Stopping the heart during ONCAB procedures may also impair or damage heart muscle. In addition, clamping the aorta has been associated in some studies with the release of thrombogenic agents that may contribute to stroke risk. These concerns have encouraged some surgeons to move toward off-pump and minimally invasive CABG techniques.

Alternative Treatments in Competing Markets

Alternative treatments in adjacent cardiovascular markets continue to limit expansion of the cardiac surgery device market. Cardiovascular disease can often be treated with products and procedures included in interventional cardiology, including percutaneous coronary interventions.

Pharmaceutical treatment also plays an important role in cardiovascular disease management. In some cases, drug therapy may delay or reduce the need for surgical or device-based intervention.

As interventional and pharmaceutical options continue to develop, some patients may be treated outside the cardiac surgery device market. This creates competitive pressure on certain surgical segments, especially when less invasive alternatives are available.

Market Coverage and Data Scope

• Quantitative coverage: Market size, market shares, procedure numbers, market forecasts, market growth rates, units sold, and average selling prices.
• Qualitative coverage: Market drivers and limiters, competitive analysis, recent mergers and acquisitions, company profiles, product portfolios, and leading competitors.
• Time frame: Base year 2025, forecasts to 2032, and historical data back to 2022.
• Market modeling: Revenue is analyzed using unit sales and ASPs, supported by procedure numbers, competitive share analysis, and forecast assumptions.
• Device scope: The report covers tissue heart valves, mechanical heart valves, annuloplasty repair devices, transcatheter mitral valve repair devices, transcatheter tricuspid valve repair devices, transcatheter heart valve replacement devices, cerebral embolic protection devices, balloon valvuloplasty devices, coronary artery bypass devices, autotransfusion devices, endoscopic vessel harvesting devices, anastomosis assist devices, ventricular assist devices, intra-aortic balloon devices, artificial heart replacement devices, defect closure devices, left atrial appendage closure devices, preshaped guidewires, and ECMO products.

Markets Covered and Segmentation

Tissue Heart Valve Market

• Device type: Stented, stentless, and sutureless heart valves.

Mechanical Heart Valve Market

The mechanical heart valve market is analyzed as part of the global cardiac surgery device market.

Annuloplasty Repair Device Market

The annuloplasty repair device market is included within the broader valve repair segment.

Transcatheter Mitral Valve Repair Market

This segment covers TMVr devices used in mitral valve repair procedures.

Transcatheter Tricuspid Valve Repair Market

This segment covers TTVr devices used in tricuspid valve repair procedures.

Transcatheter Heart Valve Replacement Market

• Device type: Transcatheter aortic valve replacement and transcatheter pulmonary valve replacement.

Cerebral Embolic Protection Device Market

This segment covers devices used to reduce embolic risk during certain cardiac interventions.

Balloon Valvuloplasty Device Market

• Device type: Aortic, mitral, and pulmonary devices.

On-Pump Coronary Artery Bypass Device Market

• Device type: ONCAB disposables and perfusion systems.

Off-Pump Coronary Artery Bypass Device Market

• Device type: Stabilizer devices and positioners.

Autotransfusion Device Market

• Device type: Autotransfusion machines and autotransfusion disposables.

Endoscopic Vessel Harvesting Device Market

This segment covers products used to harvest vessels for bypass procedures.

Anastomosis Assist Device Market

This segment covers devices used to support vessel connection during bypass procedures.

Ventricular Assist Device Market

• Device type: Implantable and percutaneous VADs.

Intra-Aortic Balloon Device Market

• Device type: IAB catheters and IABP consoles.

Artificial Heart Replacement Device Market

This segment covers artificial heart replacement products.

Patent Foramen Ovale Closure Device Market

This segment covers devices used to close patent foramen ovale defects.

Patent Ductus Arteriosus Closure Device Market

This segment covers PDA closure devices.

Atrial and Ventricular Septal Defect Closure Device Market

• Device type: Atrial septal and ventricular septal defect closure devices.

Left Atrial Appendage Closure Device Market

• Device type: Endocardial, epicardial clip, and epicardial suture LAA devices.

Preshaped Guidewire Market

This segment is indicated for TAVR procedures.

Extracorporeal Membrane Oxygenation Market

• Device type: ECMO disposables and ECMO machines.

Transmyocardial Revascularization Device Market

This segment is captured as an appendix.

Competitive Analysis

Abbott emerged as the leading competitor in the global cardiac surgery device market in 2025. The company maintains a broad and diversified portfolio across multiple cardiac surgery segments and competes strongly in most geographic markets.

Abbott is well positioned to expand its cardiac surgery presence. In August 2025, its Navitor(TM) transcatheter aortic valve implantation system received CE Mark approval for an expanded indication to treat a broader population with aortic stenosis. Abbott also received regulatory approval for its TriClip(R) system in Japan in July 2025, supporting its position in the transcatheter mitral and tricuspid intervention markets.

Edwards Lifesciences was the second-leading competitor in 2025. Although the company participates in five cardiac surgery segments, it maintained a leading position in most of those areas, except transcatheter mitral and tricuspid valve repair devices. In May 2025, its SAPIEN 3 TAVR platform received FDA approval for treating patients with asymptomatic severe aortic stenosis.

Medtronic was the third-leading competitor in 2025. Its position is supported by a broad portfolio spanning tissue and mechanical heart valves, annuloplasty repair systems, transcatheter heart valves, ONCAB and OPCAB devices, autotransfusion systems, and preshaped guidewires. In 2024, Medtronic launched the VitalFlow(TM) ECMO system and introduced Avalus Ultra(TM), its next-generation surgical aortic tissue valve.

Technology and Practice Trends

Earlier Diagnosis Through Advanced Imaging

CT and MRI improvements are enabling earlier and more accurate detection of structural heart and valvular disease. This is expanding the diagnosed patient population and increasing referrals for treatment.

Earlier diagnosis is expected to support procedural growth across valve repair, valve replacement, and other cardiac intervention segments.

Transcatheter Treatment Expansion

Transcatheter procedures remain one of the most important trends in cardiac surgery devices. These procedures reduce the need for open-heart surgery in selected patients and are especially important for elderly or high-risk populations.

TAVI, TMVr, and TTVr are expected to remain major growth areas through 2032.

Growth in Tricuspid Intervention

Tricuspid regurgitation is becoming a more recognized treatment area. Better screening and imaging are helping identify patients who previously may not have received intervention.

This trend supports growing demand for transcatheter tricuspid valve repair devices.

Large Structural Heart Portfolios

Leading competitors are building broader structural heart portfolios. Companies with strong valve repair, valve replacement, closure, and circulatory support platforms are well positioned to compete across multiple segments.

This supports cross-segment growth and strengthens account-level relationships with hospitals.

Minimally Invasive CABG and Off-Pump Techniques

Concerns related to ONCAB procedures have supported interest in off-pump and minimally invasive CABG approaches.

Products that reduce procedural trauma, shorten recovery, or avoid cardiopulmonary bypass may benefit from this trend.

ECMO and Mechanical Support Innovation

ECMO and ventricular assist technologies are important areas of continued innovation. These devices support patients with severe cardiopulmonary failure or advanced heart failure.

Product launches such as Medtronic's VitalFlow(TM) ECMO system reflect ongoing development in advanced cardiac support.

Geography

This report provides global coverage across North America, Europe, Asia-Pacific, Latin America, the Middle East, and Africa.

1,316 pages of detailed market analysis, tables, and figures.

Why This Report

• How large is the global cardiac surgery device market today, and how much is it expected to grow through 2032?
• Which cardiac surgery device segments are driving the strongest growth?
• How are unit sales, procedure numbers, ASPs, and market values changing across global markets?
• How are CT and MRI advancements affecting diagnosis, referrals, and procedural demand?
• What role do transcatheter valve repair and replacement technologies play in future growth?
• How are TAVI and TTVr changing the treatment landscape for structural heart disease?
• What impact do anticoagulant requirements have on mechanical heart valve adoption?
• How are ONCAB-related risks influencing the shift toward off-pump and minimally invasive techniques?
• Which companies lead the global cardiac surgery device market?
• How are Abbott, Edwards Lifesciences, and Medtronic positioned across major cardiac surgery segments?

The Global Cardiac Surgery Device Market Report from iData Research answers these questions with device-level analysis, procedure-based modeling, ASP data, company share insights, and forecasts through 2032. Use it to evaluate demand, benchmark competitors, understand structural heart and surgical technology trends, and support commercial planning in the global cardiac surgery device market.

TABLE OF CONTENT

List of Figures

List of Charts

executive summary

Global Cardiac Surgery Device Market Overview

Competitive Analysis

Market Trends

Market Developments

Procedures Included

Markets Included

Regions Included

Key Report Updates

Version History

research methodology

• Step 1: Project Initiation & Team Selection
• Step 2: Prepare Data Systems and Perform Secondary Research
• Step 3: Preparation for Interviews & Questionnaire Design
• Step 4: Performing Primary Research
• Step 5: Research Analysis: Establishing Baseline Estimates
• Step 6: Market Forecast and Analysis
• Step 7: Identify Strategic Opportunities
• Step 8: Final Review and Market Release
• Step 9: Customer Feedback and Market Monitoring

Impact of global tariffs

Disease Overview

• 3.1 Basic Anatomy
• 3.2 Disease Treatments & Diagnostics
  • 3.2.1 Coronary Artery Disease
  • 3.2.2 Myocardial Infarction
  • 3.2.3 Angina Pectoris
  • 3.2.4 Heart Valve Disease
  • 3.2.5 Congestive Heart Failure
  • 3.2.6 Aortic Stenosis
  • 3.2.7 Degenerative/Functional Mitral Regurgitation
• 3.3 Patient Demographics
  • 3.3.1 General Statistics
  • 3.3.2 Coronary Artery Disease
  • 3.3.3 Myocardial Infarction
  • 3.3.4 Angina Pectoris
  • 3.3.5 Heart Valve Disease
  • 3.3.6 Congestive Heart Failure

Global Cardiac surgery device Market Overview

• 4.1 Introduction
• 4.2 Market Overview & Trend Analysis
  • 4.2.1 By Segment
  • 4.2.2 By Region
• 4.3 Drivers and Limiters
  • 4.3.1 Market Drivers
  • 4.3.2 Market Limiters
• 4.4 Competitive Market Share Analysis
• 4.5 Mergers and Acquisitions
• 4.6 Company Profiles
  • 4.6.1 Abbott
  • 4.6.2 Abiomed
  • 4.6.3 Artivion
  • 4.6.4 AtriCure
  • 4.6.5 B. Braun
  • 4.6.6 Boston Scientific
  • 4.6.7 Edwards Lifesciences
  • 4.6.8 Getinge
  • 4.6.9 LivaNova
  • 4.6.10 Medtronic
  • 4.6.11 Terumo

Tissue heart valve Market

• 5.1 Executive Summary
  • 5.1.1 Global Tissue Heart Valve Market Overview
  • 5.1.2 Competitive Analysis
  • 5.1.3 Procedures Included
  • 5.1.4 Markets Included
  • 5.1.5 Regions Included
• 5.2 Introduction
• 5.3 Procedure Numbers
  • 5.3.1 Total Tissue Heart Valve Procedures
  • 5.3.2 Aortic Tissue Heart Valve Procedures
  • 5.3.3 Mitral Tissue Heart Valve Procedures
  • 5.3.4 Tricuspid Tissue Heart Valve Procedures
  • 5.3.5 Pulmonary Tissue Heart Valve Procedures
• 5.4 Market Overview
  • 5.4.1 By Segment
  • 5.4.2 By Region
• 5.5 Market Analysis and Forecast
  • 5.5.1 Total Tissue Heart Valve Market
  • 5.5.2 Stented Tissue Heart Valve Market
  • 5.5.3 Stentless Tissue Heart Valve Market
  • 5.5.4 Sutureless Tissue Heart Valve Market
• 5.6 Drivers and Limiters
  • 5.6.1 Market Drivers
  • 5.6.2 Market Limiters
• 5.7 Competitive Market Share Analysis

Mechanical Heart Valve Market

• 6.1 Executive Summary
  • 6.1.1 Global Mechanical Heart Valve Market Overview
  • 6.1.2 Competitive Analysis
  • 6.1.3 Procedures Included
  • 6.1.4 Regions Included
• 6.2 Introduction
• 6.3 Procedure Numbers
  • 6.3.1 Total Mechanical Heart Valve Procedures
  • 6.3.2 Aortic Mechanical Heart Valve Procedures
  • 6.3.3 Mitral Mechanical Heart Valve Procedures
  • 6.3.4 Tricuspid Mechanical Heart Valve Procedures
  • 6.3.5 Pulmonary Mechanical Heart Valve Procedures
• 6.4 Market Analysis and Forecast
• 6.5 Drivers and Limiters
  • 6.5.1 Market Drivers
  • 6.5.2 Market Limiters
• 6.6 Competitive Market Share Analysis

Annuloplasty Repair Device Market

• 7.1 Executive Summary
  • 7.1.1 Global Annuloplasty Repair Device Market Overview
  • 7.1.2 Competitive Analysis
  • 7.1.3 Procedures Included
  • 7.1.4 Regions Included
• 7.2 Introduction
• 7.3 Procedure Numbers
  • 7.3.1 Total Annuloplasty Repair Valve Procedures
  • 7.3.2 Mitral Annuloplasty Repair Procedures
  • 7.3.3 Tricuspid Annuloplasty Repair Procedures
• 7.4 Market Analysis and Forecast
• 7.5 Drivers and Limiters
  • 7.5.1 Market Drivers
  • 7.5.2 Market Limiters
• 7.6 Competitive Market Share Analysis

Transcatheter Mitral Valve Repair Market

• 8.1 Executive Summary
  • 8.1.1 Global Transcatheter Mitral Valve Repair Market Overview
  • 8.1.2 Competitive Analysis
  • 8.1.3 Procedures Included
  • 8.1.4 Regions Included
• 8.2 Introduction
• 8.3 Procedure Numbers
• 8.4 Market Analysis and Forecast
• 8.5 Drivers and Limiters
  • 8.5.1 Market Drivers
  • 8.5.2 Market Limiters
• 8.6 Competitive Market Share Analysis

TRANSCATHETER TRICUSPID VALVE REPAIR MARKET

• 9.1 Executive Summary
  • 9.1.1 Global Transcatheter Tricuspid Valve Repair Market Overview
  • 9.1.2 Competitive Analysis
  • 9.1.3 Procedures Included
  • 9.1.4 Regions Included
• 9.2 Introduction
• 9.3 Procedure Numbers
• 9.4 Market Analysis and Forecast
• 9.5 Drivers and Limiters
  • 9.5.1 Market Drivers
  • 9.5.2 Market Limiters
• 9.6 Competitive Market Share Analysis