Cardiac Assist Devices Market to Grow at 13.7% CAGR with FDA Breakthroughs and Pipeline Momentum from Abbott, Medtronic, and Abiomed | DelveInsight

Cardiac Assist Devices Market to Grow at 13.7% CAGR with FDA Breakthroughs and Pipeline Momentum from Abbott, Medtronic, and Abiomed | DelveInsight
Cardiac Assist Devices Market Insights, Competitive Landscape, and Market Forecast – 2030
The Cardiac Assist Devices market, valued at $3B in 2023, is set to reach $6.23B by 2030 at a CAGR of 13.7%. Key players include Abbott (NYSE: ABT), Teleflex (NYSE: TFX), SynCardia, St. Jude Medical, Carmat (Euronext Paris: ALCAR.PA), CorWave, Medtronic (NYSE: MDT), Terumo, Abiomed (NASDAQ: ABMD), Berlin Heart, BiVACOR, and Magenta Medical. Emerging innovations like BiVACOR’s Total Artificial Heart, Magenta’s Elevate, and BrioHealth’s BrioVAD are reshaping heart failure care.

DelveInsight’s “Cardiac Assist Devices Market Insights, Competitive Landscape, and Market Forecast – 2030” report delivers a comprehensive analysis of the Cardiac Assist Device market, covering historical and forecasted potential patient pools, competitive landscape and market outlook across the globe through 2030.

Key Takeaways

  • Market size projection: As per DelveInsight’s analysis, the total cardiac assist devices market size is expected to surge significantly by 2030, reaching USD 6.23 billion globally with a robust CAGR of 13.70% during the forecast period from 2024 to 2030.

  • Patient population data: The report provides comprehensive coverage of the cardiac assist devices market across multiple patient segments, including those requiring Bridge-To-Transplant (BTT) therapy, destination therapy, and Bridge-To-Candidacy (BTC) therapy, addressing the critical need for heart failure management solutions.

  • Key companies: Leading cardiac assist device companies include Abbott Laboratories (NYSE: ABT), Teleflex Incorporated (NYSE: TFX), SynCardia Systems LLC, St. Jude Medical Inc., Carmat SA (Euronext Paris: ALCAR.PA), CorWave SA, Medtronic plc (NYSE: MDT), Terumo Heart Inc., Abiomed Inc. (NASDAQ: ABMD), Berlin Heart GmbH, BiVACOR Inc., and Magenta Medical, among others.

  • Pipeline assets: Key cardiac assist emerging device include the BiVACOR Total Artificial Heart (BTAH), BrioVAD System by BrioHealth Solutions, Magenta Medical’s Elevate heart pump, and CARMAT’s advanced total artificial heart for biventricular heart failure patients.

  • In August 2025, BrioHealth Solutions received FDA approval to proceed with the Pivotal Phase of their INNOVATE trial after completing the Safety Phase. The INNOVATE (Investigation of a Novel, magNetically levitated VAD for the treatment of refractOry left Ventricular heArT failurE) trial is evaluating the BrioVAD System against the current standard HeartMate 3 LVAD.

  • In July 2025, CorWave announced the world’s first implantation of its Left Ventricular Assist System (LVAS) based on breakthrough wave membrane technology.

  • In January 2025, FIRE1 received FDA Breakthrough Device Designation for its Norm heart failure management system and was accepted into the FDA’s Total Product Lifecycle Advisory Program (TAP).

Recent tariff measures enacted in 2025 have introduced a baseline 10% duty on most Chinese imports affecting Cardiac Assist Devices supply chains, with derivative tariffs of 25% on steel and aluminum components taking effect in March 2025. Know more about how the companies are navigating these tariff tensions @ Cardiac Assist Devices Recent Developments.

Cardiac Assist Devices Market Dynamics

The cardiac assist devices market demonstrates exceptional growth potential, with the market currently valued at USD 3 billion and projected to expand at a CAGR of 13.70% through 2030. This remarkable market momentum is driven by several critical factors that underscore the urgent need for advanced cardiac support technologies.

The primary cardiac assist devices market driver stems from the escalating global burden of cardiovascular diseases. According to Delveinsight’s analysis, approximately 620 million people worldwide, representing about 1 in 13 individuals, live with heart and circulatory diseases. The prevalence is particularly significant in Europe, with 100 million affected individuals, and in Asia-Australia with 340 million cases. Coronary heart disease alone affects an estimated 200 million people globally, with approximately 110 million men and 80 million women impacted. Additionally, around 56 million women and 45 million men are stroke survivors, while at least 13 million people worldwide live with congenital heart disease.

The scientific rationale for cardiac assist devices centers on their ability to provide mechanical circulatory support for patients with severe heart failure. These devices function by augmenting the heart’s pumping capacity, improving blood flow to vital organs, and serving as life-saving interventions for patients awaiting heart transplantation or those who are not transplant candidates. The therapeutic mechanism involves different approaches, including left ventricular assist devices (LVADs), biventricular assist devices (BIVADs), right ventricular assist devices (RVADs), artificial hearts, and intra-aortic balloon pumps.

The cardiac assist devices clinical development activity remains robust across the industry, with multiple companies advancing their pipeline assets through various trial phases. The competitive landscape is characterized by intense innovation and strategic positioning among established medical device manufacturers and emerging technology companies. Major cardiac assist device manufacturers are investing significantly in research and development to enhance device performance, reduce complications, and improve patient outcomes.

However, the market faces notable challenges, including risks of infection, mechanical complications, clot formation, and stringent regulatory requirements for product approval. Despite these hurdles, opportunities abound due to the critical shortage of donor hearts and increasing awareness of cardiovascular health. The future outlook remains highly optimistic, driven by technological advancements, expanding clinical applications, and growing acceptance of mechanical circulatory support as both bridge therapy and destination therapy for end-stage heart failure patients.

Download the Cardiac Assist Devices Market report to understand which factors are driving the therapeutic market @ Cardiac Assist Devices Market Trends.

Cardiac Assist Devices Targeted Patient Pool

The cardiac assist devices targeted patient pool reflects the substantial global burden of cardiovascular diseases requiring advanced mechanical circulatory support. The cardiac assist devices report provides crucial insights into the patient populations driving market demand. The cardiovascular disease burden spans multiple conditions, with coronary heart disease representing the most commonly diagnosed condition worldwide, affecting approximately 200 million individuals globally. The patient segmentation reveals diverse therapeutic needs, including those requiring bridge-to-transplant therapy, destination therapy for patients ineligible for transplantation, and bridge-to-candidacy therapy for patients who may become transplant eligible after stabilization.

The total eligible patient pool encompasses individuals with end-stage heart failure, severe coronary artery disease complications, and various forms of cardiogenic shock requiring mechanical circulatory support. The geographic distribution shows significant concentration in developed markets, with North America expected to dominate the overall market due to higher disease prevalence, advanced healthcare infrastructure, and greater access to innovative cardiac technologies. The United States specifically demonstrates a critical need, with more than 3.5K patients on heart transplant waiting lists and daily mortality rates of 17 individuals while awaiting organ transplantation. European and Asia-Pacific regions also represent substantial patient populations, with Europe showing 100 million individuals affected by heart and circulatory diseases.

The forecast period from 2024 to 2030 anticipates continued growth in patient populations requiring cardiac assist devices, driven by aging demographics, increasing prevalence of diabetes and hypertension, and improved survival rates leading to more advanced heart failure cases. The total treated cases are expected to expand significantly as device technology advances, clinical evidence strengthens, and healthcare systems increasingly adopt mechanical circulatory support as standard care for appropriate patient populations.

Discover evolving trends in the Cardiac Assist Devices patient pool forecasts @ Cardiac Assist Devices Patient Pool Analysis.

Key Cardiac Assist Devices Companies and Treatment Market

The clinical and regulatory landscape for cardiac assist devices encompasses a sophisticated ecosystem of established medical device manufacturers and innovative technology companies developing next-generation circulatory support systems. Current heart disease treatment options include ventricular assist devices categorized as left ventricular assist devices (LVADs), biventricular assist devices (BIVADs), and right ventricular assist devices (RVADs), along with total artificial hearts and intra-aortic balloon pumps. These devices serve various therapeutic applications, including bridge-to-transplant therapy, destination therapy for non-transplant candidates, and bridge-to-candidacy therapy.

The cardiac assist device clinical pipeline activity demonstrates robust development across multiple phases, with key cardiac assist device manufacturers advancing innovative technologies through rigorous clinical trials. Key players include Abbott Laboratories (Impella devices), Teleflex Incorporated (circulatory support solutions), SynCardia Systems LLC (total artificial heart technology), CARMAT (biventricular artificial heart), Medtronic PLC (ventricular assist devices), Abiomed (Impella heart pumps), and BiVACOR Inc (total artificial heart), along with emerging companies like BrioHealth Solutions, Magenta Medical, and Berlin Heart GmbH.

Market positioning reflects the critical role these devices play in modern cardiac care, serving as life-saving interventions for patients with end-stage heart failure. The mechanism of action varies by device type, with LVADs providing left ventricular support, artificial hearts replacing native heart function, and balloon pumps offering temporary circulatory assistance. Development status ranges from commercially available systems to investigational devices undergoing clinical trials.

Delve deeper into the major and specialised companies in the Cardiac Assist Devices market @ Cardiac Assist Devices Competitive Landscape.

Conclusion

The cardiac assist devices market represents one of the most dynamic and rapidly expanding segments in medical technology, driven by the convergence of increasing cardiovascular disease burden, technological innovation, and critical unmet medical needs. With a projected market value of USD 6.23 billion by 2030 and a robust CAGR of 13.70%, this therapeutic area offers substantial opportunities for improving patient outcomes while addressing the global shortage of donor hearts. The strong pipeline of innovative devices, combined with expanding clinical applications and growing regulatory support, positions the cardiac assist devices market for sustained growth throughout the forecast period.

Table of Contents

1. Cardiac Assist Devices Market Report Introduction

2. Cardiac Assist Devices Market Executive Summary

3. Competitive Landscape

4. Regulatory Analysis

5. Cardiac Assist Devices Market Key Factors Analysis

6. Cardiac Assist Devices Market Porter’s Five Forces Analysis

7. Cardiac Assist Devices Market Assessment

8. Cardiac Assist Devices Market Company and Product Profiles

9. KOL Views

10. Project Approach

11. About DelveInsight

12. Disclaimer & Contact Us

About DelveInsight

DelveInsight is a leading business consulting and market research company focused on the healthcare and life sciences sectors, providing comprehensive market intelligence, competitive landscape analysis, and strategic insights to support decision-making across the pharmaceutical industry.

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