NEW YORK, Aug. 2, 2024 /PRNewswire/ -- The global heart valve repair and replacement devices market size is estimated to grow by USD 2.58 billion from 2024-2028, according to Technavio. The market is estimated to grow at a CAGR of 7.08% during the forecast period. Rising competition and innovations overall heart valve repair and replacement devices market is driving market growth, with a trend towards data-oriented technologies drive growth of market. However, shortage of cardiologists poses a challenge. Key market players include Abbott Laboratories, Artivion Inc., BioStable Science and Engineering Inc., Boston Scientific Corp., Colibri Heart Valve LLC, Edwards Lifesciences Corp., JenaValve Technology Inc., LivaNova PLC, Medtronic Plc, Micro Interventional Devices Inc., Neovasc Inc., Valcare Medical, and Xeltis AG.

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Market Driver

The use of data plays a significant role in the design and development of heart valves in the healthcare industry. Manufacturers leverage data-driven technologies like IoT and artificial intelligence to create intelligent and smart heart valves. These valves collect, store, and analyze data, providing actionable insights to users in real-time. The FDA's recent approval of Siron's Solo Smart aortic pericardial heart valve, featuring sensors and data transmission technologies, has sparked competition in the market. Additional smart heart valves are expected to enter the global heart valve repair and replacement devices market, fueling its growth during the forecast period. 

The Heart Valve Repair and Replacement Devices market is witnessing significant growth due to the increasing number of surgical procedures for heart failure, stroke caused by blood clots, and diseased valves, particularly Mitral and Aortic valves. The industry is driven by FDA approvals of new technologies like Transcatheter Aortic Valve Implantation (TAVI) and Transcatheter Mitral Valve Repair (TMVR), which offer minimally invasive alternatives to traditional heart valve replacement surgeries. Key players like Medtronic and Edwards Lifesciences are making acquisitions to expand their product portfolios, which include mechanical and biological valves, percutaneous balloon-expandable and transcatheter heart valves. The high cost and regulatory procedures, with stringency increasing, remain challenges for market growth. Diagnostic technologies for congenital heart defects and cardiovascular diseases also contribute to market expansion. 

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Market Challenges

• The global heart valve repair and replacement devices market faces a significant challenge due to the shortage of skilled cardiologists. This shortage can hinder market growth during the forecast period. Factors contributing to this issue include the migration of trained specialists from developing countries to developed ones and the increasing rates of burnout among professionals. The lack of expertise in handling diagnostic and therapeutic tools can lead to misdiagnosis and improper treatment, potentially harming patients. To address this challenge, initiatives to train and retain cardiologists, as well as the adoption of advanced technologies, could help improve the situation.
• The Heart Valve Repair and Replacement Devices market is witnessing significant growth due to the increasing prevalence of cardiovascular diseases, including congenital and acquired heart defects, age-related changes, infections, heart attacks, and calcific degeneration. Two leading technologies in this field are Transcatheter Aortic Valve Implantation (TAVI) and Transcatheter Mitral Valve Repair (TMVR). TAVI, a minimally invasive procedure, has gained FDA approval and is becoming increasingly popular for Aortic Valve Replacement. However, challenges such as high cost and regulatory procedures add to the market's complexity. Companies like Medtronic and Edwards Lifesciences are making acquisitions to expand their product portfolios, offering both mechanical and tissue bioprosthetic valves. Diagnostic technologies play a crucial role in identifying the need for heart valve repair or replacement. Percutaneous balloon and transcatheter heart valves are alternatives to surgical heart valves for treating regurgitation and stenosis. Despite these advancements, challenges remain, including the stringency of regulatory procedures and the risk of damage from blood clots and infections. Industry growth drivers include the need for effective treatment for heart disease damage and the potential for lifestyle changes to reduce the risk of heart disease. Overall, the Heart Valve Repair and Replacement Devices market is expected to continue growing, offering opportunities for innovation and improvement in patient care.

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Segment Overview 

This heart valve repair and replacement devices market report extensively covers market segmentation by

1. Product 
   • 1.1 Heart valve replacement devices
   • 1.2 Heart valve repair devices
2. Geography 
   • 2.1 North America
   • 2.2 Europe
   • 2.3 Asia
   • 2.4 Rest of World (ROW)

1.1 Heart valve replacement devices- Heart valve replacement devices are essential medical solutions for individuals with damaged heart valves. These devices are categorized into mechanical, tissue/bioprosthetic, and transcatheter valves, based on the type of valve being replaced. Mechanical valves, manufactured from synthetic materials like plastic, carbon, or metal, offer durability and longevity, typically lasting up to 25 years. They are suitable for patients below 65 years of age with valve stenosis or regurgitation and a history of atrial fibrillation. However, patients require lifelong anticoagulant therapy due to the risk of blood clots. Mechanical valves are ideal for patients with small-sized hearts and are represented in the market by offerings such as Medtronic Open Pivot Mechanical Heart Valves, EDWARDS INTUITY Elite valve system, and Carbomedics Aortic Family. Tissue/bioprosthetic valves, derived from animal tissues or human donor hearts, require replacement every ten years without the need for anticoagulants. They are suitable for older populations (above 65 years) due to their susceptibility to structural degeneration in neonatal and pediatric patients. Some notable bioprosthetic valves include Mosaic and Mosaic Ultra Bioprostheses by Medtronic and The EPIC MITRAL STENDED TISSUE VALVE WITH LINX ANTICALCIFICATION (AC) technology by Abbott. Transcatheter heart valves, designed for aortic valve replacement, are implanted with minimal incisions and mild sedation, allowing for shorter hospital stays and improved survival rates for patients with aortic valve stenosis. Although associated with complications like bleeding, stroke, arrhythmias, kidney disease, infections, and heart attack, transcatheter valves are gaining popularity due to their less invasive nature. Some prominent transcatheter valves in the market include LOTUS Edge Aortic Valve System by Boston Scientific Corporation, JenaValve Pericardial TAVR System, and Evolut PRO System by Medtronic. The growing prevalence of heart valve diseases and the increasing demand for minimally invasive procedures will drive the growth of this segment during the forecast period.

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Research Analysis

Heart valves are essential components of the cardiovascular system, allowing the proper flow of blood through the heart. Heart valves can be affected by various conditions such as congenital defects, acquired diseases, age-related changes, infections, heart attacks, and calcific degeneration. These conditions can lead to damage, regurgitation, or stenosis, requiring treatment. Treatment options include medicines and lifestyle changes, as well as advanced technologies like Transcatheter Aortic Valve Replacement (TAVR) and Transcatheter Mitral Valve Replacement (TMVR), which are minimally invasive alternatives to traditional open-heart surgery. FDA approval and regulatory procedures play a crucial role in the market, with stringency increasing due to the high cost and potential risks associated with heart valve repair and replacement. Diagnostic technologies help identify heart valve issues early, enabling timely intervention. Cardiovascular diseases, including heart disease, remain a significant driver for the market.

Market Research Overview

Heart valves are essential components of the cardiovascular system that control the flow of blood in and out of the heart. Damage to heart valves can result from congenital defects, age-related changes, infections, heart attacks, calcific degeneration, and other heart diseases. Damaged valves can lead to regurgitation or stenosis, which can cause heart failure, stroke, blood clots, and even death. Treatment options include medicines, lifestyle changes, and surgical procedures. Heart valve repair and replacement devices are used to treat diseased valves, including the mitral and aortic valves. Prosthetic valves, such as mechanical and biological valves, are commonly used for replacement. Transcatheter aortic valve replacement (TAVR) and transcatheter aortic valve implantation (TAVI) are minimally invasive procedures for aortic valve replacement. The industry is driven by the growing prevalence of cardiovascular diseases, the aging population, and the need for minimally invasive procedures. Regulatory procedures and stringency are key considerations in the market, with the FDA approving various devices and technologies, including transcatheter heart valves, percutaneous heart valves, and tissue bioprosthetic valves. Industry growth is also driven by acquisitions, such as Medtronic's acquisition of Edwards Lifesciences, and the development of new diagnostic technologies for congenital heart defects. However, the high cost of these devices and regulatory procedures can limit market growth.

Table of Contents:

1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation

• Product
• • Heart Valve Replacement Devices
  • Heart Valve Repair Devices
• Geography
• • North America
  • Europe
  • Asia
  • Rest Of World (ROW)

7 Customer Landscape
8 Geographic Landscape
9 Drivers, Challenges, and Trends
10 Company Landscape
11 Company Analysis
12 Appendix

About Technavio

Technavio is a leading global technology research and advisory company. Their research and analysis focuses on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions.

With over 500 specialized analysts, Technavio's report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio's comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios.

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SOURCE Technavio