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PUBLISHER: Grand View Research | PRODUCT CODE: 1772227

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PUBLISHER: Grand View Research | PRODUCT CODE: 1772227

U.S. Balloon Valvuloplasty Devices Market Size, Share & Trends Analysis Report By Application (Aortic Valve Stenosis, Pulmonary Valve Stenosis), By End Use (Hospitals, Ambulatory Surgical Centers), And Segment Forecasts, 2025 - 2033

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Market Size & Trends:

The U.S. balloon valvuloplasty devices market size was estimated at USD 820.1 million in 2024 and is expected to grow at a CAGR of 3.4% from 2025 to 2033. Rheumatic heart disease (RHD) is a critical cardiovascular disorder caused by permanent damage to the heart valves following an episode of rheumatic fever. As the prevalence of valvular heart diseases continues to rise across the U.S., affecting an estimated 2.5% of the population, particularly among older adults, the need for effective treatment options has grown substantially.

RHD often results in severe valve dysfunction, which frequently necessitates interventional procedures such as balloon valvuloplasty to restore normal valve function and improve patient outcomes. This growing clinical need drives market expansion, fueled by advancements in minimally invasive procedures and increasing awareness of early valve disease intervention. Technological innovations continue to drive market growth. As highlighted in a publication by Elsevier Inc. in August 2023, recent advancements in balloon aortic valvuloplasty (BAV) have significantly enhanced its clinical value, especially when used as a transitional therapy before transcatheter aortic valve replacement (TAVR).

Over the past 20 years, substantial progress has been made in balloon catheter technology, including developing improved End Uses and designs contributing to better procedural success rates. In addition, improvements in ventricular pacing techniques and arterial access methods, such as enhanced percutaneous femoral access, have helped lower the risks associated with BAV, making the procedure safer and more reliable. These technological breakthroughs have renewed interest in BAV, particularly as a short-term option for patients who are not immediate candidates for TAVR.

Advancements in technology have enhanced the feasibility of balloon aortic valvuloplasty (BAV), with clinicians becoming increasingly proficient in managing large-bore access and the overall procedural workflow. Improved balloon catheter designs and the accuracy of modern imaging tools have led to better procedural outcomes. Nonetheless, questions remain about the long-term effectiveness of BAV, especially as the growing success of transcatheter aortic valve replacement (TAVR) continues to challenge the procedure's role in contemporary treatment strategies.

Regulations play a critical role in shaping the U.S. market by upholding safety, effectiveness, and quality benchmarks. While strict regulatory standards can slow down the approval process, potentially delaying product launches and hindering innovation, they also contribute to greater patient trust and consistent device performance. In the long run, these regulations support market growth by ensuring that only thoroughly tested and reliable devices are approved for clinical use.

U.S. Balloon Valvuloplasty 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, Grand View Research has segmented the U.S. balloon valvuloplasty devices market report based on treatment and end use:

  • Application Outlook (Revenue, USD Million, 2021 - 2033)
  • Aortic Valve Stenosis
  • Pulmonary Valve Stenosis
  • End Use Outlook (Revenue, USD Million, 2021 - 2033)
  • Hospitals
  • Ambulatory Surgical Centers (ASCs)
  • Cardiac Catheterization Labs
Product Code: GVR-4-68040-641-9

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Market Segmentation & Scope
  • 1.2. Segment Definitions
    • 1.2.1. Application
    • 1.2.2. End Use
    • 1.2.3. Estimates and forecasts timeline
  • 1.3. Research Methodology
  • 1.4. Information Procurement
    • 1.4.1. Purchased database
    • 1.4.2. GVR's internal database
    • 1.4.3. Secondary sources
    • 1.4.4. Primary research
    • 1.4.5. Details of primary research
  • 1.5. Information or Data Analysis
    • 1.5.1. Data analysis models
  • 1.6. Market Formulation & Validation
  • 1.7. Model Details
  • 1.8. List of Secondary Sources
  • 1.9. List of Primary Sources
  • 1.10. Objectives

Chapter 2. Executive Summary

  • 2.1. Market Outlook
  • 2.2. Segment Outlook
    • 2.2.1. Application outlook
    • 2.2.2. End Use outlook
  • 2.3. Competitive scenario

Chapter 3. U.S. Balloon Valvuloplasty Devices Market Variables, Trends, & Scope

  • 3.1. Market Lineage Outlook
    • 3.1.1. Parent market outlook
    • 3.1.2. Related/ancillary market outlook
  • 3.2. Market Dynamics
    • 3.2.1. Market driver analysis
    • 3.2.2. Market restraint analysis
  • 3.3. U.S. Balloon Valvuloplasty Devices Market Analysis Tools
    • 3.3.1. Industry Analysis - Porter's
      • 3.3.1.1. Supplier power
      • 3.3.1.2. Buyer power
      • 3.3.1.3. Substitution threat
      • 3.3.1.4. Threat of new entrants
      • 3.3.1.5. Competitive rivalry
    • 3.3.2. PESTEL Analysis
      • 3.3.2.1. Political landscape
      • 3.3.2.2. Technological landscape
      • 3.3.2.3. Economic landscape

Chapter 4. U.S. Balloon Valvuloplasty Devices Market: Application Estimates & Trend Analysis

  • 4.1. Application Segment Dashboard
  • 4.2. U.S. Balloon Valvuloplasty Devices Market: Application Movement Analysis
  • 4.3. U.S. balloon valvuloplasty devices market Size & Trend Analysis, By Application, 2021 to 2033 (USD Million)
  • 4.4. Aortic Valve Stenosis
    • 4.4.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
  • 4.5. Pulmonary Valve Stenosis
    • 4.5.1. Market estimates and forecasts, 2021 - 2033 (USD Million)

Chapter 5. U.S. Balloon Valvuloplasty Devices Market: End Use Estimates & Trend Analysis

  • 5.1. End Use Segment Dashboard
  • 5.2. U.S. Balloon Valvuloplasty Devices Market: End Use Movement Analysis
  • 5.3. U.S. balloon valvuloplasty devices market Size & Trend Analysis, By End Use, 2021 to 2033 (USD Million)
  • 5.4. Hospitals
    • 5.4.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
  • 5.5. Ambulatory Surgical Centers (ASCs)
    • 5.5.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
  • 5.6. Cardiac Catheterization Labs
    • 5.6.1. Market estimates and forecasts, 2021 - 2033 (USD Million)

Chapter 6. Competitive Landscape

  • 6.1. Recent Developments & Impact Analysis, By Key Market Participants
  • 6.2. Company/Competition Categorization
  • 6.3. Company market share analysis, 2024
  • 6.4. Company Profiles/Listing
    • 6.4.1. B. Braun Interventional Systems, Inc
      • 6.4.1.1. Company overview
      • 6.4.1.2. Financial performance
      • 6.4.1.3. Application benchmarking
      • 6.4.1.4. Strategic initiatives
    • 6.4.2. BD
      • 6.4.2.1. Company overview
      • 6.4.2.2. Financial performance
      • 6.4.2.3. Application benchmarking
      • 6.4.2.4. Strategic initiatives
    • 6.4.3. Edwards Lifesciences Corporation
      • 6.4.3.1. Company overview
      • 6.4.3.2. Financial performance
      • 6.4.3.3. Application benchmarking
      • 6.4.3.4. Strategic initiatives
    • 6.4.4. Boston Scientific Corporation
      • 6.4.4.1. Company overview
      • 6.4.4.2. Financial performance
      • 6.4.4.3. Application benchmarking
      • 6.4.4.4. Strategic initiatives
    • 6.4.5. Getinge
      • 6.4.5.1. Company overview
      • 6.4.5.2. Financial performance
      • 6.4.5.3. Application benchmarking
      • 6.4.5.4. Strategic initiatives
    • 6.4.6. TORAY INTERNATIONAL, INC.
      • 6.4.6.1. Company overview
      • 6.4.6.2. Financial performance
      • 6.4.6.3. Application benchmarking
      • 6.4.6.4. Strategic initiatives
    • 6.4.7. Stryker
      • 6.4.7.1. Company overview
      • 6.4.7.2. Financial performance
      • 6.4.7.3. Application benchmarking
      • 6.4.7.4. Strategic initiatives
    • 6.4.8. BrosMed Medical Co., Ltd.
      • 6.4.8.1. Company overview
      • 6.4.8.2. Financial performance
      • 6.4.8.3. Application benchmarking
      • 6.4.8.4. Strategic initiatives
    • 6.4.9. Medtronic
      • 6.4.9.1. Company overview
      • 6.4.9.2. Financial performance
      • 6.4.9.3. Application benchmarking
      • 6.4.9.4. Strategic initiatives
    • 6.4.10. Terumo Corporation
      • 6.4.10.1. Company overview
      • 6.4.10.2. Financial performance
      • 6.4.10.3. Application benchmarking
      • 6.4.10.4. Strategic initiatives
Product Code: GVR-4-68040-641-9

List of Tables

  • Table 1 List of abbreviations
  • Table 2 U.S. balloon valvuloplasty devices market, by Application, 2021 - 2033 (USD Million)
  • Table 3 U.S. balloon valvuloplasty devices market, by End Use, 2021 - 2033 (USD Million)

List of Figures

  • Fig. 1 Market research process
  • Fig. 2 Data triangulation techniques
  • Fig. 3 Primary research pattern
  • Fig. 4 Primary interviews
  • Fig. 5 Market research approaches
  • Fig. 6 Value-chain-based sizing & forecasting
  • Fig. 7 QFD modeling for market share assessment
  • Fig. 8 Market formulation & validation
  • Fig. 9 U.S. Balloon Valvuloplasty Devices Market: market outlook
  • Fig. 10 U.S. Balloon Valvuloplasty Devices Market competitive insights
  • Fig. 11 Parent market outlook
  • Fig. 12 Related/ancillary market outlook
  • Fig. 13 Penetration and growth prospect mapping
  • Fig. 14 Industry value chain analysis
  • Fig. 15 U.S. balloon valvuloplasty devices market driver impact
  • Fig. 16 U.S. balloon valvuloplasty devices market restraint impact
  • Fig. 17 U.S. balloon valvuloplasty devices market strategic initiatives analysis
  • Fig. 18 U.S. balloon valvuloplasty devices market: Application movement analysis
  • Fig. 19 U.S. balloon valvuloplasty devices market: Application outlook and key takeaways
  • Fig. 20 Aortic Valve Stenosis market estimates and forecast, 2021 - 2033
  • Fig. 21 Pulmonary Valve Stenosis market estimates and forecast, 2021 - 2033
  • Fig. 22 U.S. Balloon Valvuloplasty Devices Market: End Use movement analysis
  • Fig. 23 U.S. Balloon Valvuloplasty Devices Market: End Use outlook and key takeaways
  • Fig. 24 Hospitals market estimates and forecast, 2021 - 2033
  • Fig. 25 Ambulatory Surgical Centers (ASCs) market estimates and forecast, 2021 - 2033
  • Fig. 26 Cardiac Catheterization Labs market estimates and forecast, 2021 - 2033
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