Press release
United States Transcatheter Heart Valve Replacement Devices Industry Intelligence Report: Innovation, Growth & Industry Leaders
Transcatheter Heart Valve Replacement Devices Industry
FDA Approvals & Clinical Trials
In July/August 2025, the FDA approved expanded use of Medtronic's Evolut TAVR systems for Redo-TAVR, enabling valve-in-valve procedures for patients needing second replacements.
Edwards Sapien 3 platform received approval for less severe, asymptomatic aortic stenosis based on strong data from the EARLY TAVR trial-now, more patients can benefit from early intervention.
Several breakthrough designations and pivotal trials continue for novel mitral and tricuspid valve replacement systems; JenaValve and Innovalve's technologies received regulatory nods to begin pivotal studies in the US
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Mergers & Acquisitions
Edwards Lifesciences has been on a deal spree, acquiring Genesis Medtech's TAVR business and JenaValve Technology, plus making equity investments in Innovalve Bio Medical and Affluent Medical to expand into mitral and aortic solutions.
In June, BD (Becton Dickinson) agreed to buy Edwards' critical care group for $4.2 billion, signaling a shift in focus for Edwards Lifesciences.
List of Top Key Players:
Abbott, Edwards Lifesciences Corporation, Medtronic plc., Boston Scientific Corporation, JenaValve Technology, Inc., Meril Life Sciences, Sahajanand Medical Technologies Limited, MicroPort Scientific Corporation, Venus Medtech (Hangzhou) Inc., and Peijia Medical Limited.
Forecast Growth Projection:
Global Transcatheter Heart Valve Replacement Devices Market Positioned for Strong Growth 2025-2032, Building on the steady momentum of 2024, the market is poised for remarkable expansion as leading players embrace innovative technologies and strategic advancements. This evolving landscape is unlocking lucrative opportunities for businesses to invest, scale, and stay ahead in an increasingly competitive and fast-moving market.
Market Research Process:
The Transcatheter Heart Valve Replacement Devices Market research report by DataM Intelligence combines extensive Primary and Secondary research to provide powerful, in-depth insights. It examines key market drivers such as regulatory frameworks, evolving market conditions, competitive dynamics, historical trends, and breakthrough technologies, while spotlighting emerging innovations and potential challenges. This all-inclusive analysis uncovers high-growth opportunities and highlights possible barriers, equipping businesses to tackle market volatility and capture new avenues for success.
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Market Segments:
By Product: Self-Expandable Transcatheter Aortic Valves, Balloon Expandable Transcatheter Aortic Valves, Mechanically Expandable Transcatheter Aortic Valves
By Procedure Type: Transcatheter Aortic Valve Replacement, Transcatheter Mitral Valve Replacement, Transcatheter Pulmonary Valve Replacement
By Indication: Severe Aortic Valve Stenosis, Aortic Regurgitation, Others
By End-Users: Hospitals, Ambulatory Surgical Centers, Cardiac Catheterization Laboratories
Product Launches
Several new-generation TAVR devices have hit the market, targeting improved procedural safety and long-term patient outcomes; Edwards, Medtronic, Abbott, and Boston Scientific remain market leaders.
Abbott has launched the Navitor Vision in India, extending next-gen transcatheter valve technology to new geographic markets.
Modular and dry-storage TAVR valves debuted globally, making procedures more flexible and accessible for complex patient cases.
Global Growth Regions:
⇥ North America (U.S., Canada, Mexico)
⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)
⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)
⇥ South America (Colombia, Brazil, Argentina, Rest of South America)
⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)
Benefits of the Report:
Chapter 1: Opens the report with a comprehensive market overview, highlighting key segments by region, product type, and application. It presents a clear snapshot of market size, growth potential by segment, and both short- and long-term outlook.
Chapter 2: Showcases the most impactful insights, uncovering the emerging trends and disruptive forces shaping the industry's future.
Chapter 3: Delivers an in-depth competitive landscape analysis of the Transcatheter Heart Valve Replacement Devices market, covering revenue shares, strategic moves, and the latest mergers & acquisitions.
Chapter 4: Features detailed profiles of leading players, including their revenue streams, profit margins, product portfolios, and key milestones.
Chapters 5 & 6: Present a granular breakdown of regional and country-level revenue performance, offering a precise view of market size, opportunities, and development prospects worldwide.
Chapter 7: Analyzes market segmentation by product type, revealing the growth potential of each category and spotlighting high-impact.
Chapter 8: Examines application-based market growth, identifying the fastest-expanding sectors and lucrative opportunities for expansion.
Chapter 9: Maps the entire industry supply chain, providing insights into upstream and downstream activities for a complete market perspective.
Chapter 10: Concludes with key findings and actionable takeaways, guiding stakeholders toward strategic decisions and future growth opportunities.
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Company Name: DataM Intelligence
Contact Person: Sai Kiran
Email: Sai.k@datamintelligence.com
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About Us -
DataM Intelligence is a Market Research and Consulting firm that provides end-to-end business solutions to organizations from Research to Consulting. We, at DataM Intelligence, leverage our top trademark trends, insights and developments to emancipate swift and astute solutions to clients like you. We encompass a multitude of syndicate reports and customized reports with a robust methodology.
Our research database features countless statistics and in-depth analyses across a wide range of 6300+ reports in 40+ domains creating business solutions for more than 200+ companies across 50+ countries; catering to the key business research needs that influence the growth trajectory of our vast clientele.
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