The global percutaneous mechanical circulatory support devices market reached US$ 2.35 billion in 2024 and is expected to reach US$ 5.20 billion by 2033, growing at a CAGR of 8.7% during the forecast period of 2025-2033.
Percutaneous mechanical circulatory support devices are advanced medical tools created to offer temporary support to patients suffering from severe heart failure or cardiogenic shock. These devices are essential for stabilizing hemodynamic status and maintaining sufficient blood flow to critical organs until more permanent treatment options can be applied.
These devices boost the heart's capacity to pump blood efficiently, which is vital for patients with weakened cardiac function. By providing support to the heart, these devices help reduce the pressure in the heart's chambers, thereby relieving stress on the heart.
Market Dynamics: Drivers & Restraints
Increasing Prevalence of Cardiovascular Diseases
Cardiovascular diseases (CVDs) are a major global health concern, ranking among the primary contributors to illness and death worldwide. The incidence of acute myocardial infarction (heart attacks) and chronic heart failure is on the rise, fueled by an aging population, sedentary lifestyles, unhealthy dietary patterns, and the growing prevalence of obesity and diabetes. The rising prevalence of heart-related issues, including acute myocardial infarction and chronic heart failure, is driving healthcare providers to utilize percutaneous mechanical circulatory support (pMCS) devices to improve patient outcomes during critical medical procedures.
According to a study published in the American Heart Association's journal Circulation in June 2024, the number of adults affected by cardiovascular disease (CVD) and stroke is projected to rise significantly over the next three decades. The researchers estimate that by 2050, clinical CVD will impact 45 million adults, while the total number of individuals affected by CVD, including hypertension, will exceed 184 million, accounting for over 61% of the adult population. All these factors demand the global percutaneous mechanical circulatory support devices market.
Product Recalls
Product recalls represent a significant restraint in the global percutaneous mechanical circulatory support (pMCS) devices market, directly impacting the reliability and reputation of key players in the industry. These devices, which include ventricular assist devices, intra-aortic balloon pumps, and extracorporeal support systems, are crucial for patients suffering from acute cardiac failure.
Getinge has faced multiple recalls for its circulatory support devices, notably the Cardiosave Intra-Aortic Balloon Pump and the Cardiohelp System. Between January 2023 and April 2024, the FDA reported 12 voluntary recalls for the Cardiosave pump, with eight classified as Class I, the most serious type. These recalls were due to device malfunctions linked to serious injuries and deaths.
Also, in July 2023, Abiomed issued an urgent medical device correction for its Impella 2.5 intravascular micro axial blood pump due to risks of impeller blade destruction in patients with certain heart valve replacements, which could lead to low blood flow and embolization. Thus, the above factors could be limiting the global percutaneous mechanical circulatory support devices market's potential growth.
Segment Analysis
The global percutaneous mechanical circulatory support devices market is segmented based on device type, application, end-user, and region.
Device Type:
The impella devices segment in device type is expected to dominate the global percutaneous mechanical circulatory support devices market with the highest market share
Impella devices are compact ventricular assist devices inserted through the femoral artery and positioned in the left ventricle. They pump blood from the left ventricle into the ascending aorta, maintaining systemic perfusion at rates ranging from 2.5 to 5.0 liters per minute. This mechanism helps to offload the left ventricle and rapidly increases overall cardiac output. By providing immediate hemodynamic support, Impella devices reduce the workload on the left ventricle while augmenting blood flow to the body's vital organs.
Moreover, major players in the industry have innovative product launches & approvals, and key developments in circulatory support devices help to drive this segment growth in the market. For instance, in September 2022, the U.S. Food and Drug Administration (FDA) granted two approvals concerning the clinical research of Abiomed’s Impella heart pumps. The FDA has authorized the on-label RECOVER IV randomized controlled trial (RCT) to evaluate the use of Impella heart pumps in patients experiencing acute myocardial infarction (AMI) with cardiogenic shock. Abiomed has indicated that the two-arm study protocol has received FDA approval to utilize the Exception from Informed Consent (EFIC) pathway for enrolling participants.
Also, in April 2022, Abiomed announced the first successful implants of its Impella Bridge-to-Recovery (BTR) device as part of an early feasibility study. The Impella BTR is a forward-flow heart pump that is implanted through the axillary artery and positioned in the left ventricle. Designed to pump over six liters of blood per minute, this device is less invasive than traditional left ventricular assist devices (LVADs) and offers patients with chronic heart failure a longer-term, minimally invasive option for heart support. These factors have solidified the segment's position in the global percutaneous mechanical circulatory support devices market.
Geographical Analysis
North America is expected to hold a significant position in the global percutaneous mechanical circulatory support devices market with the highest market share
The rising elderly population in the U.S. is a significant factor in the increasing prevalence of cardiovascular diseases. Older individuals are more vulnerable to heart-related issues, leading to heightened demand for advanced treatment solutions such as percutaneous mechanical circulatory support (pMCS) devices.
According to projections from the U.S. Census Bureau in January 2024, the number of Americans aged 100 and older is expected to more than quadruple over the next three decades, rising from an estimated 101,000 in 2024 to approximately 422,000 by 2054Currently, centenarians represent just 0.03% of the total U.S. population, but this figure is anticipated to increase to 0.1% by 2054.
The growing number of individuals diagnosed with cardiovascular diseases, particularly heart failure and acute myocardial infarction, is a key factor driving the demand for percutaneous mechanical circulatory support (pMCS) devices in the U.S. As more patients necessitate interventions for severe cardiac conditions, the requirement for efficient mechanical support technologies becomes increasingly crucial.
Moreover, a major number of key players are present, financial investments in mechanical circulatory support devices, well-advanced healthcare infrastructure, and innovative product launches are driving this market growth. For instance, in July 2024, Magenta Medical, an Israeli company, secured $105 million to advance trials for its Elevate device, touted as the world's smallest heart pump. The company is preparing for pivotal trials in the United States as it seeks FDA approval for its use in mechanical circulatory support applications.
Also, in May 2024, the HeartMate 3 is an advanced left ventricular assist device (LVAD) developed by Abbott for patients with severe heart failure. Thus, the above factors are consolidating the region's position as a dominant force in the global percutaneous mechanical circulatory support devices market.
Competitive Landscape
The major global players in the percutaneous mechanical circulatory support devices market include Abbott, Berlin Heart, Medtronic, Teleflex Incorporated, Getinge, ABIOMED, Boston Scientific Corporation, LivaNova, Inc., EUROSETS, and Evaheart, Inc., among others.
Key Developments
• In April 2024, Cadrenal Therapeutics, Inc., a biopharmaceutical company focused on developing tecarfarin, announced a partnership with Abbott to advance this innovative anticoagulant for patients with left ventricular assist devices (LVADs). This collaboration aims to enhance anticoagulation therapy for individuals with implanted cardiac devices, addressing a significant unmet need in cardiovascular treatment.
• In October 2022, Eurosets, a medical device company based in Medolla, Italy, launched Colibrì, a groundbreaking extracorporeal life support (ECLS) system that is the lightest of its kind currently available on the market. Colibrì is designed to provide temporary support for patients experiencing ventricular failure, cardiac arrest, or respiratory failure in various applications, including extracorporeal membrane oxygenation (ECMO), extracorporeal cardiopulmonary resuscitation (E-CPR), and mechanical circulatory support (MCS).
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• Pipeline & Innovations: Reviews ongoing clinical trials and product pipelines and forecasts upcoming advancements in medical devices and pharmaceuticals.
• Product Performance & Market Positioning: Analyzed product performance, market positioning, and growth potential to optimize strategies.
• Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
• Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
• Market Updates & Industry Changes: This covers recent regulatory changes, new policies, and emerging technologies.
• Competitive Strategies: Analyze competitor strategies, market share, and emerging players.
• Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
• Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
• Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
• Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
• Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
• Post-market Surveillance: Uses post-market data to enhance product safety and access.
• Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.
The global percutaneous mechanical circulatory support devices market report delivers a detailed analysis with 62 key tables, more than 54 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.
Target Audience 2024
• Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
• Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
• Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
• Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
• Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
• Supply Chain: Distribution and Supply Chain Managers.
• Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
• Academic & Research: Academic Institutions.
- 1. Market Introduction and Scope
- 1.1. Objectives of the Report
- 1.2. Report Coverage & Definitions
- 1.3. Report Scope
- 2. Executive Insights and Key Takeaways
- 2.1. Market Highlights and Strategic Takeaways
- 2.2. Key Trends and Future Projections
- 2.3. Snippet by Device Type
- 2.4. Snippet by Application
- 2.5. Snippet by End-User
- 2.6. Snippet by Region
- 3. Dynamics
- 3.1. Impacting Factors
- 3.1.1. Drivers
- 3.1.1.1. Increasing Prevalence of Cardiovascular Diseases
- 3.1.1.2. Advancements in Technology
- 3.1.1.3. XX
- 3.1.2. Restraints
- 3.1.2.1. Product Recalls
- 3.1.2.2. High Cost of Devices and Procedures
- 3.1.2.3. XX
- 3.1.3. Opportunity
- 3.1.3.1. Expansion into Emerging Markets
- 3.1.3.2. XX
- 3.1.4. Impact Analysis
- 4. Strategic Insights and Industry Outlook
- 4.1. Market Leaders and Pioneers
- 4.1.1. Emerging Pioneers and Prominent Players
- 4.1.2. Established leaders with the largest-selling Brand
- 4.1.3. Market leaders with established Product
- 4.2. CXO Perspectives
- 4.3. Latest Developments and Breakthroughs
- 4.4. Regulatory and Reimbursement Landscape
- 4.4.1. North America
- 4.4.2. Europe
- 4.4.3. Asia Pacific
- 4.4.4. South America
- 4.4.5. Middle East & Africa
- 4.5. Porter’s Five Forces Analysis
- 4.6. Supply Chain Analysis
- 4.7. Patent Analysis
- 4.8. SWOT Analysis
- 4.9. Unmet Needs and Gaps
- 4.10. Recommended Strategies for Market Entry and Expansion
- 4.11. Scenario Analysis: Best-Case, Base-Case, and Worst-Case Forecasts
- 4.12. Pricing Analysis and Price Dynamics
- 4.13. Key Opinion Leaders
- 5. Percutaneous Mechanical Circulatory Support Devices Market, By Device Type
- 5.1. Introduction
- 5.1.1. Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 5.1.2. Market Attractiveness Index By Device Type
- 5.2. Intra-Aortic Balloon Pump (IABP)*
- 5.2.1. Introduction
- 5.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
- 5.3. Left Ventricular Assist Devices (LVAD)
- 5.3.1. Continuous-flow LVADs
- 5.3.2. Pulsatile-flow LVADs
- 5.4. Extracorporeal Life Support (ECLS)
- 5.5. Impella Devices
- 6. Percutaneous Mechanical Circulatory Support Devices Market, By Application
- 6.1. Introduction
- 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 6.1.2. Market Attractiveness Index By Application
- 6.2. Cardiogenic Shock *
- 6.2.1. Introduction
- 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
- 6.3. High-Risk Percutaneous Coronary Interventions (PCI)
- 6.4. Cardiac Arrest
- 7. Percutaneous Mechanical Circulatory Support Devices Market, By End-User
- 7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 7.1.2. Market Attractiveness Index, By End-User
- 7.2. Hospitals *
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
- 7.3. Specialty Cardiology Centers
- 7.4. Ambulatory Surgical Center
- 7.5. Others
- 8. Percutaneous Mechanical Circulatory Support Devices Market, By Regional Market Analysis and Growth Opportunities
- 8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 8.1.2. Market Attractiveness Index, By Region
- 8.2. North America
- 8.2.1. Introduction
- 8.2.2. Key Region-Specific Dynamics
- 8.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 8.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 8.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 8.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
- 8.2.6.1. U.S.
- 8.2.6.2. Canada
- 8.2.6.3. Mexico
- 8.3. Europe
- 8.3.1. Introduction
- 8.3.2. Key Region-Specific Dynamics
- 8.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 8.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 8.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 8.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
- 8.3.6.1. Germany
- 8.3.6.2. U.K.
- 8.3.6.3. France
- 8.3.6.4. Spain
- 8.3.6.5. Italy
- 8.3.6.6. Rest of Europe
- 8.4. South America
- 8.4.1. Introduction
- 8.4.2. Key Region-Specific Dynamics
- 8.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 8.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 8.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 8.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
- 8.4.6.1. Brazil
- 8.4.6.2. Argentina
- 8.4.6.3. Rest of South America
- 8.5. Asia-Pacific
- 8.5.1. Introduction
- 8.5.2. Key Region-Specific Dynamics
- 8.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 8.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 8.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 8.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
- 8.5.6.1. China
- 8.5.6.2. India
- 8.5.6.3. Japan
- 8.5.6.4. South Korea
- 8.5.6.5. Rest of Asia-Pacific
- 8.6. Middle East and Africa
- 8.6.1. Introduction
- 8.6.2. Key Region-Specific Dynamics
- 8.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 8.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 8.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 9. Competitive Landscape and Market Positioning
- 9.1. Competitive Overview and Key Market Players
- 9.2. Market Share Analysis and Positioning Matrix
- 9.3. Strategic Partnerships, Mergers & Acquisitions
- 9.4. Key Developments in Product Portfolios and Innovations
- 9.5. Company Benchmarking
- 10. Company Profiles
- 10.1. Abbott*
- 10.1.1. Company Overview
- 10.1.2. Product Portfolio
- 10.1.2.1. Product Description
- 10.1.2.2. Product Key Performance Indicators (KPIs)
- 10.1.2.3. Historic and Forecasted Product Sales
- 10.1.2.4. Product Sales Volume
- 10.1.3. Financial Overview
- 10.1.3.1. Company Revenue
- 10.1.3.2. Geographical Revenue Shares
- 10.1.3.3. Revenue Forecasts
- 10.1.4. Key Developments
- 10.1.4.1. Mergers & Acquisitions
- 10.1.4.2. Key Product Development Activities
- 10.1.4.3. Regulatory Approvals, etc.
- 10.1.5. SWOT Analysis
- 10.2. Berlin Heart
- 10.3. Medtronic
- 10.4. Teleflex Incorporated.
- 10.5. Getinge
- 10.6. ABIOMED.
- 10.7. Boston Scientific Corporation
- 10.8. LivaNova, Inc.
- 10.9. EUROSETS
- 10.10. Evaheart, Inc.
- LIST NOT EXHAUSTIVE
- 11. Assumptions and Research Methodology
- 11.1. Data Collection Methods
- 11.2. Data Triangulation
- 11.3. Forecasting Techniques
- 11.4. Data Verification and Validation
- 12. Appendix
- 12.1. About Us and Services
- 12.2. Contact Us
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