The Global Heart Valve Repair and Replacement Devices Market was valued at USD 7,346.40 Million in 2023 and is projected to reach USD 12,948.55 Million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 6.50% during the forecast period (2023–2032). This growth is being driven by an aging global population, rising incidence of valvular heart diseases, and the rapid adoption of minimally invasive transcatheter technologies in hospitals and clinics worldwide.
As the cardiovascular sector evolves toward less invasive treatments and improved patient outcomes, attention turns to the leading medical device manufacturers pioneering innovative solutions for heart valve disorders. In this blog, we profile the Top 10 Companies in the Heart Valve Repair and Replacement Devices Market—a blend of established medtech giants and specialists innovating in surgical and transcatheter valve therapies to enhance cardiac health globally.
🔟 1. CryoLife Inc.
Headquarters: Kennesaw, Georgia, USA
Key Offering: Tissue-based heart valves, repair patches, and cryopreserved allografts
CryoLife Inc., now operating as part of Artivion, stands as a prominent provider of biological heart valve solutions, focusing on allograft and xenograft technologies for both repair and replacement procedures. Their portfolio caters to complex cases in congenital heart defects and endocarditis, serving surgeons in over 80 countries through a network of distribution partners. The company’s emphasis on tissue preservation techniques ensures durability and biocompatibility, reducing the risk of rejection in patients undergoing valve surgery.
With a strong presence in the surgical segment, CryoLife continues to expand its offerings by integrating advanced cryopreservation methods that maintain valve integrity for longer shelf life. This approach not only supports immediate availability during emergencies but also aligns with the growing demand for personalized cardiac interventions. Furthermore, their devices are widely used in pediatric cardiology, where preserving natural tissue is crucial for long-term growth.
Innovation Initiatives:
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Development of On-X aortic and mitral valves with proven long-term performance
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Partnerships with leading cardiac centers for clinical trials on tissue-engineered valves
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Commitment to expanding access in emerging markets through training programs for surgeons
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9️⃣ 2. Sorin Group
Headquarters: Milan, Italy (legacy operations under LivaNova)
Key Offering: Mechanical and biological heart valves, annuloplasty rings
Sorin Group, now integrated into LivaNova, has a storied history in cardiac surgery, providing reliable mechanical valves like the Bicarbon series and biological options for aortic and mitral positions. Their devices are engineered for durability, with low thrombogenicity features that minimize anticoagulation needs post-implantation. Serving a global clientele, Sorin’s contributions have been pivotal in advancing open-heart procedures since the mid-20th century.
The legacy of Sorin lies in its focus on precision engineering, where each valve undergoes rigorous testing to ensure hemodynamic performance comparable to native valves. This has made their products a staple in high-volume cardiac centers across Europe and beyond. As part of larger entities today, these innovations continue to influence modern repair techniques, particularly in combination with ring annuloplasty for valve preservation.
Innovation Initiatives:
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Advancements in carbon-based mechanical valves for reduced clotting risks
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Collaborations on hybrid procedures combining repair and replacement
8️⃣ 3. LivaNova PLC
Headquarters: London, United Kingdom
Key Offering: Perceval sutureless valves, Mitroflow biological valves, repair systems
LivaNova PLC is a key innovator in sutureless and biological valve technologies, with the Perceval valve revolutionizing aortic replacement by reducing surgical time significantly. Their devices are designed for minimally invasive approaches, appealing to surgeons aiming to shorten recovery periods for elderly patients. Operating in more than 100 countries, LivaNova supports cardiac care through comprehensive training and clinical evidence from large-scale studies.
Building on the Sorin heritage, LivaNova emphasizes patient-centric design, incorporating bioengineered tissues that mimic natural valve function. This has led to improved outcomes in terms of durability and reduced reoperation rates. Their repair devices, including chordal systems, offer alternatives to full replacement, preserving native tissue whenever possible and enhancing quality of life for patients with degenerative valve diseases.
Innovation Initiatives:
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Expansion of sutureless valve platforms for broader anatomical compatibility
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Investment in clinical registries tracking long-term valve performance
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Global partnerships to integrate valves with 3D imaging for precise implantation
7️⃣ 4. Boston Scientific Corporation
Headquarters: Marlborough, Massachusetts, USA
Key Offering: Lotus Edge transcatheter valves, Watchman devices for adjunct therapy
Boston Scientific Corporation excels in transcatheter aortic valve replacement (TAVR) with its Lotus system, featuring a repositionable design that allows for optimal placement during procedures. Their focus on structural heart interventions extends to repair clips for mitral regurgitation, addressing a common complication post-valve surgery. With a robust R&D pipeline, the company serves major hospitals worldwide, emphasizing ease of use for interventional cardiologists.
The company’s commitment to iterative improvements is evident in their valve iterations, which incorporate adaptive seals to prevent paravalvular leaks—a frequent challenge in TAVR. By leveraging data from real-world evidence, Boston Scientific refines its offerings to match evolving patient demographics, particularly the younger cohorts now eligible for these therapies. This positions them strongly in the shift toward outpatient cardiac procedures.
Innovation Initiatives:
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Targets for next-generation TAVR with smaller delivery systems
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Strategic alliances with imaging companies for enhanced procedural guidance
Download FREE Sample Report: Heart Valve Repair and Replacement Devices Market – View in Detailed Research Report
6️⃣ 5. Abbott Laboratories
Headquarters: Abbott Park, Illinois, USA
Key Offering: MitraClip repair system, Amplatzer occluders, structural heart valves
Abbott Laboratories leads in percutaneous mitral valve repair through the MitraClip, a clip-based technology that reduces regurgitation without open surgery, transforming treatment for high-risk patients. Their structural heart portfolio includes TAVR options acquired from St. Jude Medical, providing comprehensive solutions for both repair and replacement across aortic and mitral valves. Abbott’s global reach ensures accessibility in diverse healthcare settings.
With a focus on evidence-based innovation, Abbott invests heavily in randomized trials demonstrating the efficacy of their devices in improving survival rates and symptoms. The integration of digital tools for post-procedure monitoring further enhances their value proposition, allowing for remote follow-up and early detection of complications. This holistic approach supports the transition to value-based care in cardiology.
Innovation Initiatives:
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Enhancements to clip delivery for complex anatomies
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Aims for net-zero emissions in manufacturing by 2035 while advancing device biocompatibility
5️⃣ 6. Terumo Corporation
Headquarters: Tokyo, Japan
Key Offering: Aortic and mitral bioprosthetic valves, transcatheter delivery systems
Terumo Corporation brings Japanese precision to the heart valve market with its bioprosthetic valves designed for low-profile implantation, minimizing trauma in surgical settings. Their innovations in catheter-based delivery support hybrid operating rooms, blending surgical and interventional techniques. Terumo serves Asian and international markets, with a growing footprint in Europe and North America through strategic acquisitions.
Emphasizing material science, Terumo’s valves feature anti-calcification treatments to extend longevity, addressing a key limitation of biological implants. This has earned them recognition in guidelines for valve selection, particularly for patients seeking durable, non-mechanical options. Their commitment to education includes simulation labs for training on advanced implantation methods.
Innovation Initiatives:
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Current focus on expandable valves for pediatric applications
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Target expansion to 1 million procedures annually by 2028
4️⃣ 7. Medtronic PLC
Headquarters: Dublin, Ireland (global ops in Minneapolis, USA)
Key Offering: CoreValve Evolut TAVR platform, Mosaic surgical valves
Medtronic PLC is a powerhouse in transcatheter technologies, with the Evolut series dominating TAVR procedures due to its self-expanding design and recapturable features. Offering a full spectrum from surgical replacements to repair accessories, Medtronic supports over a million patients annually worldwide. Their devices are backed by extensive clinical data, ensuring regulatory approvals across major regions.
The company’s strategy involves continuous refinement, such as reducing valve size for smaller vessels, broadening eligibility to lower-risk patients. By fostering collaborations with key opinion leaders, Medtronic drives adoption of next-gen therapies, including valve-in-valve procedures for failed implants. This forward-thinking approach solidifies their role in shaping minimally invasive cardiology.
Innovation Initiatives:
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Ongoing trials for next-gen TAVR in bicuspid valves
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Integration of AI for procedural planning
3️⃣ 8. Braile Biomédica
Headquarters: São José do Rio Preto, Brazil
Key Offering: Custom pericardial valves, repair rings
Braile Biomédica emerges as a significant player in Latin America, specializing in handmade pericardial valves tailored to patient anatomy for optimal fit. Their affordable yet high-quality devices address regional healthcare needs, with exports growing in developing markets. Braile’s focus on local manufacturing reduces costs while maintaining international standards.
Through rigorous quality controls, Braile ensures their valves perform comparably to global brands in durability tests. They play a vital role in expanding access to advanced care in underserved areas, supported by training initiatives for local surgeons. As globalization accelerates, Braile’s innovations in customizable solutions position them for broader impact.
Innovation Initiatives:
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Research into bioabsorbable repair materials
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Public-private partnerships to scale production in emerging economies
2️⃣ 9. JenaValve Technology
Headquarters: Munich, Germany
Key Offering: JenaValve Trilogy TAVR system for aortic regurgitation
JenaValve Technology specializes in TAVR for high-risk patients with aortic regurgitation, using a unique positioning system that anchors to native leaflets for precise deployment. Their devices target niche segments where traditional TAVR falls short, gaining traction in Europe following CE mark approvals. JenaValve’s dedication to anatomical specificity enhances safety and efficacy.
With a pipeline focused on expanding indications, JenaValve invests in computational modeling to predict valve performance pre-procedure. This data-driven method reduces complications, appealing to centers specializing in complex cases. As regulations evolve, their innovations contribute to personalized medicine in valvular disease management.
Innovation Initiatives:
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Aims for FDA approval and US market entry by 2025
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Expansion of supply chains for global distribution
1️⃣ 10. Edwards Lifesciences Corporation
Headquarters: Irvine, California, USA
Key Offering: Sapien TAVR valves, Cardioband repair system, surgical bioprostheses
Edwards Lifesciences Corporation tops the list as the global leader in heart valve therapies, with the Sapien platform setting the standard for TAVR since its inception. Their comprehensive lineup includes balloon-expandable valves, mitral repair bands, and next-gen surgical options like the Magna Ease. Serving thousands of procedures daily, Edwards drives the majority of market share through unmatched clinical evidence and innovation.
Their success stems from a relentless pursuit of excellence, incorporating patient-specific data to refine designs that improve flow dynamics and durability. Edwards’ ecosystem includes educational resources and simulation tools, empowering healthcare providers worldwide. As the field advances, their leadership ensures continued breakthroughs in reducing procedural risks and enhancing recovery.
Innovation Initiatives:
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End-to-end solutions integrating repair and replacement for complex cases
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Strategic partnerships with regulatory bodies and hospitals for accelerated adoption
Read Full Report: Heart Valve Repair and Replacement Devices Market – View in Detailed Research Report
🌍 Outlook: The Future of Heart Valve Repair and Replacement Devices Is Minimally Invasive and Patient-Centered
The heart valve repair and replacement devices market is experiencing transformative changes. While surgical options remain foundational, investments are surging in transcatheter innovations, bioengineering, and integrated delivery systems to meet rising demands from an aging demographic.
📈 Key Trends Shaping the Market:
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Expansion of TAVR indications to younger, lower-risk patients in North America and Europe
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Regulatory incentives for 5-15% adoption of repair over replacement by 2030
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Digital twins and AI for preoperative planning and customization
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Collaborations between device makers and surgeons for hybrid procedure development
Market Trends Affecting Heart Valve Repair and Replacement Devices
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Consolidation among medtech giants (Medtronic, Abbott) — streamlines innovation pipelines but demands vigilance on product compatibility and intellectual property in mergers. Recent deals are redefining competitive dynamics.
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Shift to minimally invasive and transcatheter approaches — companies are prioritizing low-profile devices and robotic assistance to cut recovery times and hospital stays. Edwards Lifesciences’ advancements exemplify this trend.
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Integration of digital health and monitoring — remote sensors and apps for post-implant tracking (Boston Scientific, Medtronic) are vital for chronic care management in ambulatory settings.
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Patient-specific and bioresorbable devices — 3D-printed valves and absorbable scaffolds reduce long-term complications, favored in pediatric and young adult cases. LivaNova leads in adaptable designs.
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Automation and AI in manufacturing and surgery — precision robotics and predictive analytics (Abbott, Terumo) lessen operator variability and boost outcomes in high-volume centers.
Read Full Report: Heart Valve Repair and Replacement Devices Market – View in Detailed Research Report
The companies listed above are not only transforming cardiac interventions—they’re spearheading the era of precision cardiovascular medicine.