The U.S. aortic valve replacement devices market size was estimated at USD 4.56 Billion in 2025 and is projected to reach USD 9.35 billion by 2033, growing at a CAGR of 9.4% from 2025 to 2033. The market is primarily driven by the increasing prevalence of aortic stenosis in an aging population and favorable clinical outcomes from surgical and transcatheter approaches.
With a growing number of patients over age 65, demand for surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) continues to rise. Clinical outcomes have improved significantly over the past decade, with TAVR gaining wider acceptance due to its less invasive nature and reduced recovery times. As per the article on the Southwestern Medical Center website, approximately 100,000 TAVR procedures are performed annually in the U.S and as of November 2024, the medical centre had performed more than 1,000 transcatheter aortic valve replacement (TAVR) procedures.
Innovation remains a critical driving force within this market, with a strong focus on enhancing device durability and improving delivery systems for less invasive procedures. Manufacturers are continuously investing in research and development to extend the lifespan of prosthetic valves, which is crucial for younger patients who may live longer with their implanted devices.
Merger and acquisition is moderately high, driven by strategic efforts to gain technological advantages or market access. In July 2024, Edwards Lifesciences announced a strategic investment of around USD 1.2 billion to acquire JenaValve Technology and Endotronix, expanding its structural heart portfolio. Acquiring JenaValve Technology enhances Edward’s position in the U.S. aortic valve replacement devices industry, targeting the underserved aortic regurgitation segment. The purchase of Endotronix, following an earlier investment, allows Edwards to enter heart failure management with its FDA-approved Cordella sensor. These strategic moves aim to address unmet patient needs and support long-term growth.
The FDA requires extensive clinical trials and post-market surveillance, which can delay product launches and ensure high safety standards. In May 2025, the FDA approved Edwards Lifesciences Sapien 3 Ultra Resilia TAVR valves for treating asymptomatic severe aortic stenosis (AS).
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With a growing number of patients over age 65, demand for surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) continues to rise. Clinical outcomes have improved significantly over the past decade, with TAVR gaining wider acceptance due to its less invasive nature and reduced recovery times. As per the article on the Southwestern Medical Center website, approximately 100,000 TAVR procedures are performed annually in the U.S and as of November 2024, the medical centre had performed more than 1,000 transcatheter aortic valve replacement (TAVR) procedures.
Innovation remains a critical driving force within this market, with a strong focus on enhancing device durability and improving delivery systems for less invasive procedures. Manufacturers are continuously investing in research and development to extend the lifespan of prosthetic valves, which is crucial for younger patients who may live longer with their implanted devices.
Merger and acquisition is moderately high, driven by strategic efforts to gain technological advantages or market access. In July 2024, Edwards Lifesciences announced a strategic investment of around USD 1.2 billion to acquire JenaValve Technology and Endotronix, expanding its structural heart portfolio. Acquiring JenaValve Technology enhances Edward’s position in the U.S. aortic valve replacement devices industry, targeting the underserved aortic regurgitation segment. The purchase of Endotronix, following an earlier investment, allows Edwards to enter heart failure management with its FDA-approved Cordella sensor. These strategic moves aim to address unmet patient needs and support long-term growth.
The FDA requires extensive clinical trials and post-market surveillance, which can delay product launches and ensure high safety standards. In May 2025, the FDA approved Edwards Lifesciences Sapien 3 Ultra Resilia TAVR valves for treating asymptomatic severe aortic stenosis (AS).
U.S. Aortic Valve Replacement Devices Market Report Segmentation
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, the analyst has segmented the U.S. aortic valve replacement devices market report based on product, leaflet material, frame material, and end use.Product Outlook (Revenue, USD Billion, 2021-2033)
- Balloon-expandable
- Self-expandable
- Mechanically expandable
- Aortic regurgitation
Leaflet Material Outlook (Revenue, USD Billion, 2021-2033)
- Bovine pericardium
- Porcine pericardium
Frame Material Outlook (Revenue, USD Billion, 2021-2033)
- Cobalt-chromium
- Nitinol
- Others
End Use Outlook (Revenue, USD Billion, 2021-2033)
- Inpatient Facilities
- Outpatient Facilities
Why should you buy this report?
- Comprehensive Market Analysis: Gain detailed insights into the market across major regions and segments.
- Competitive Landscape: Explore the market presence of key players.
- Future Trends: Discover the pivotal trends and drivers shaping the future of the market.
- Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.
This report addresses:
- Market intelligence to enable effective decision-making
- Market estimates and forecasts from 2018 to 2030
- Growth opportunities and trend analyses
- Segmental and regional revenue forecasts for market assessment
- Competition strategy and market share analysis
- Product innovation listings for you to stay ahead of the curve
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Table of Contents
Chapter 1. Methodology and Scope
Chapter 2. Executive Summary
Chapter 3. U.S. Aortic Valve Replacement Devices Market Variable Trends & Scope
Chapter 4. U.S. Aortic Valve Replacement Devices Market: Product Estimates & Trend Analysis
Chapter 5. U.S. Aortic Valve Replacement Devices Market: Leaflet Material Estimates & Trend Analysis
Chapter 6. U.S. Aortic Valve Replacement Devices Market: by Frame Material Estimates & Trend Analysis
Chapter 7. U.S. Aortic Valve Replacement Devices Market: by End Use Estimates & Trend Analysis
Chapter 8. Competitive Landscape
List of Tables
List of Figures
Companies Mentioned
The leading players profiled in this U.S. Aortic Valve Replacement Devices market report include:- oston Scientific Corporation
- rtivion, Inc
- dwards Lifesciences Corporation
- ivaNova PLC
- edtronic
- bbott
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 80 |
| Published | September 2025 |
| Forecast Period | 2025 - 2033 |
| Estimated Market Value ( USD | $ 4.56 Billion |
| Forecasted Market Value ( USD | $ 9.35 Billion |
| Compound Annual Growth Rate | 9.4% |
| Regions Covered | United States |
| No. of Companies Mentioned | 7 |
