Annuloplasty System Market – By Rigidity (Flexible, Rigid, Semi-rigid), By Application (Mitral Valve Repair, Tricuspid Valve Repair, Aortic Valve Repair), By Shape (Open, Closed), By End-use (Hospitals, ASCs, Catheterization Labs) & Forecast, 2024 – 2032

Annuloplasty System Market Size

Annuloplasty System Market size was valued at USD 473.9 million in 2023 and is anticipated to witness growth at a CAGR of 8.2% between 2024 and 2032, driven by the rising burden of cardiovascular diseases coupled with the surging demand for minimally invasive procedures.

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Cardiovascular diseases (CVDs), including conditions such as mitral valve regurgitation and tricuspid valve insufficiency are on the rise globally due to factors such as aging populations, sedentary lifestyles, unhealthy dietary habits, and increasing prevalence of risk factors like hypertension and diabetes. For instance, according to the American College of Cardiology, global death counts due to CVD increased from 12.4 million in 1990 to 19.8 million in 2022. As the incidence of these conditions continues to grow, there is an increasing demand for interventions such as annuloplasty systems to address valvular defects and restore cardiac function.
 

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Moreover, patients are increasingly opting for minimally invasive procedures over traditional open-heart surgeries due to several advantages, including reduced postoperative pain, shorter hospital stays, faster recovery times, and improved cosmetic outcomes. Consequently, annuloplasty systems that support minimally invasive approaches, such as robotic-assisted surgery or percutaneous interventions, are favored by patients seeking less invasive treatment options for valvular disorders.

An annuloplasty system comprises annuloplasty rings and bands, which are medical devices utilized in cardiac surgery to repair or reconstruct the fibrous ring surrounding heart valves, particularly the mitral and tricuspid valves. These structural heart devices are engineered to restore the natural shape, size, and function of the valve annulus, thereby improving valve leaflet coaptation, reducing valve regurgitation, and restoring proper valve function.

Annuloplasty System Market Trends

• Technological advancements in annuloplasty systems play a pivotal role in shaping the landscape of valvular heart disease treatment. These innovative systems, comprising annuloplasty rings and bands, are revolutionizing the way clinicians repair and reconstruct heart valves, offering enhanced durability, precision, and patient outcomes.
• Ongoing technological innovations have led to the development of annuloplasty systems with improved durability and longevity. Advanced materials, such as biocompatible polymers and alloy combinations, are being utilized to construct annuloplasty rings and bands that exhibit greater resistance to wear, corrosion, and deformation over time.
• For instance, Kalangos annuloplasty ring developed by Bioring SA is made from biodegradable polymer called polydioxanone, which allows it to degrade over time. These cardiovascular devices are designed to induce the growth of autologous fibrous tissue, reinforcing the deficient annulus.
• Moreover, technological advancements have enabled the incorporation of innovative design features into annuloplasty systems, enhancing their efficacy and performance. For instance, the contour 3D annuloplasty ring is a remodeling ring with a unique 3D curvature based on computed tomography (CT) data from functional tricuspid valves.
• Additionally, advanced imaging technologies, such as echocardiography and MRI systems, aid in the precise positioning and placement of annuloplasty devices during surgery, ensuring optimal valve function and long-term durability.
• Thus, technological advancements in annuloplasty systems, characterized by enhanced durability, innovative design, compatibility with minimally invasive approaches, and biocompatibility, are factors driving growth of annuloplasty systems market.

Annuloplasty System Market Analysis

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Based on rigidity, the market is segmented into flexible, rigid, and semi-rigid. Rigid and semi-rigid annuloplasty systems typically consist of annuloplasty rings, whereas flexible annuloplasty systems are commonly in the form of annuloplasty bands. The rigid segment held a significant market share of 44.1% in 2023.

• Rigid annuloplasty rings are designed to provide strong structural support to the mitral or tricuspid valve annulus, enhancing stability and durability. The rigid framework helps maintain the shape and integrity of the annulus, preventing excessive dilation or deformation that can lead to valve regurgitation or other complications.
• Additionally, rigid annuloplasty rings are associated with lower rates of recurrent valve regurgitation compared to flexible. The rigid support provided by these devices helps maintain proper leaflet coaptation and annular geometry over time, reducing the likelihood of recurrent insufficiency and the need for re-intervention.
• The versatility of rigid devices allows surgeons to tailor the repair approach to individual patient anatomy and pathology, ensuring optimal outcomes, thereby fueling the growth of this segment.

Based on application, the annuloplasty system market is classified into mitral valve repair, tricuspid valve repair, and aortic valve repair. The mitral valve repair segment accounted for the highest market share and was valued at USD 240.8 million in 2023.

• Mitral valve disease, including mitral regurgitation and mitral stenosis, is one of the most common heart valve disorders worldwide. For instance, according to a study published by the National Institutes of Health, in 2023, mitral regurgitation (MR) affects over 2% of the total world population and has a prevalence that increases with age.
• The mitral valve is susceptible to various structural abnormalities and functional deficiencies that can lead to valve dysfunction and regurgitation. As a result, there is a high demand for mitral valve repair procedures to restore valve function and prevent complications associated with mitral valve disease.
• Annuloplasty is a fundamental component of mitral valve repair procedures, providing structural support to the mitral annulus and optimizing valve coaptation and function.
• Annuloplasty systems, including both rigid and flexible devices, play a crucial role in stabilizing the mitral annulus, reducing annular dilation, and restoring valve competence. As a result, annuloplasty is routinely incorporated into mitral valve repair surgeries to achieve durable and reliable outcomes, further fueling the market growth.

Based on shape, the annuloplasty system market is classified into open and closed. The closed segment accounted for the dominant market share and was valued at USD 309.6 million in 2023.

• Closed annuloplasty systems which typically corresponds to annuloplasty rings provide consistent and uniform support around the entire circumference of the valve annulus, promoting optimal coaptation of the valve leaflets. This configuration helps maintain proper leaflet alignment and closure, minimizing the risk of residual regurgitation and improving valve function post-repair.
• Moreover, the closed shape of annuloplasty systems offers greater annular stability compared to open or C-shaped alternatives. By encircling the entire annulus in a continuous loop, closed-shaped devices distribute tension evenly along the annular circumference, preventing annular dilation and deformation during the cardiac cycle. This enhanced stability contributes to sustained valve integrity and durability over time.
• Furthermore, these systems are versatile and compatible with various surgical techniques for mitral or tricuspid valve repair. Surgeons can tailor the size and shape of the device to match individual patient anatomy and pathology, allowing for customized valve repair solutions that address specific structural abnormalities or functional impairments, resulting in enhanced adoption of these systems.

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Based on end-use, the annuloplasty system market is categorized into hospitals, ambulatory surgical centers, cardiac catheterization labs, and other end-users. The hospitals segment is projected to reach USD 421.6 million by 2032.

• Hospitals serve as central hubs for cardiovascular care, offering comprehensive diagnostic, therapeutic, and surgical services to patients with valvular heart disease. As primary providers of cardiac surgery, hospitals are equipped with specialized operating rooms, advanced medical equipment, and experienced surgical teams capable of performing complex valve repair procedures, including annuloplasty.
• The multidisciplinary nature of hospital settings enables collaboration among cardiologists, cardiac surgeons, anesthesiologists, and other healthcare professionals involved in the management of valvular disorders. This coordinated approach ensures comprehensive preoperative evaluation, intraoperative care, and postoperative management of patients undergoing annuloplasty, optimizing treatment outcomes and patient safety.
  Moreover, many hospitals have dedicated cardiac care units equipped with specialized cardiac monitoring systems, hemodynamic support devices, and critical care infrastructure to manage patients undergoing cardiac surgery, including annuloplasty. These specialized units provide intensive postoperative care, continuous hemodynamic monitoring, and timely intervention for complications, ensuring optimal recovery and outcomes for patients.

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North America annuloplasty system market size in 2023 was valued at USD 198.5 million and is predicted to grow at a CAGR of 7.8% over the analysis timeframe.

• North America dominates the market due to its strong healthcare products industry and stringent regulatory environment.
• The region boasts a robust healthcare infrastructure with state-of-the-art medical facilities, advanced surgical technologies, and skilled healthcare professionals. This enables the widespread adoption of annuloplasty systems for mitral and tricuspid valve repair procedures across the region.
• Moreover, the availability of comprehensive reimbursement policies and insurance coverage for cardiac surgeries, including annuloplasty procedures, encourages healthcare facilities and patients to opt for these interventions.
• This facilitates access to annuloplasty systems and promotes their widespread use in clinical practice, thereby propelling the growth of this market.

U.S. annuloplasty system market is anticipated to grow at a CAGR of 7.7% to reach USD 362.7 million by the end of the forecast timeframe.

• The prevalence of valvular heart disease is significant in the U.S. For instance, according to the Centers for Disease Control and Prevention, valvular heart disease affects 2.5% of the population and 13% of persons aged 80 years and older. As a result, there is a substantial demand for annuloplasty systems to address these conditions and improve patient outcomes.
• Furthermore, the U.S. is a hub for medical innovation and research, with numerous medical device companies and academic institutions driving advancements in cardiac surgery techniques and technologies.
• This fosters the development of innovative annuloplasty systems tailored to the needs of patients and surgeons.

France annuloplasty system is projected to grow remarkably in the coming years.

• France boasts a renowned healthcare system characterized by its high-quality medical facilities, skilled healthcare professionals, and comprehensive coverage of cardiac care services. This facilitates the widespread adoption of annuloplasty systems for mitral and tricuspid valve repair surgeries.
• Moreover, French medical centers and academic institutions are recognized for their clinical excellence in cardiac surgery and research. Leading cardiac surgeons and researchers contribute to the advancement of annuloplasty techniques and technologies, further enhancing the market for these devices in the country.

Japan is experiencing high market growth in the annuloplasty system market.

• Japan has one of the most rapidly aging populations globally, leading to a high prevalence of age-related cardiovascular diseases, including valvular heart disease. The increasing incidence of these conditions fuels the demand for annuloplasty systems to address structural abnormalities and improve cardiac function.
• Furthermore, Japanese medical device companies are known for their innovation and expertise in developing advanced cardiac devices and surgical instruments. This includes annuloplasty systems tailored to the specific needs of Japanese patients and clinicians, driving the adoption of these devices in the market.

Annuloplasty System Market Share

The annuloplasty system industry is characterized by the presence of several established and emerging players that offer a variety of products and services across the globe. The market players compete based on factors such as product quality, innovation, regulatory compliance, customer service, and pricing strategies.

Annuloplasty system Market Companies

Prominent players operating in the annuloplasty system industry include

• Abbott Laboratories
• Affluent Medical
• BioStable Science & Engineering
• Corcym UK Limited
• Coroneo
• Edwards Lifesciences Corporation
• Genesee BioMedical
• Medtentia International Ltd Oy
• Medtronic plc
• Micro Interventional Devices Incorporated

Annuloplasty System Industry News

• In June 2021, LivaNova and CORCYM completed the initial closing relating to CORCYM's acquisition of the LivaNova heart valve business. Additionally, CORCYM acquired LivaNova manufacturing facilities in Saluggia and Burnaby (Vancouver) and related assets in other geographies, representing most of the heart valve business. This acquisition enabled the company to diversify into new business domains and capitalize on emerging opportunities.

The annuloplasty system market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 - 2032 for the following segments

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Market, By Rigidity

• Flexible
• Rigid
• Semi-rigid

Market, By Application

• Mitral valve repair
• Tricuspid valve repair
• Aortic valve repair

Market, By Shape

• Open
• Closed

Market, By End-use

• Hospitals
• Ambulatory surgical centers
• Cardiac catheterization labs
• Other end-users

The above information is provided for the following regions and countries

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of Middle East and Africa