美国球囊瓣环成形设备市场规模、份额、应用趋势分析报告、最终用途、细分市场预测，2025-2033

市场规模与趋势：

预计 2024 年美国球囊瓣环成形术设备市场价值将达到 8.201 亿美元，预计 2025 年至 2033 年的复合年增长率为 3.4%。

风湿性心臟疾病(RHD) 是一种严重的心血管疾病，由风湿热发作后心臟瓣膜的永久性损伤引起。在美国，瓣膜性心臟病的盛行率持续上升，尤其是在老年人群中，估计影响到 2.5% 的人口，因此对有效治疗方案的需求巨大。

风湿性心臟病 (RHD) 通常会导致严重的瓣膜功能障碍，通常需要球囊瓣环成形等介入性治疗来恢復正常的瓣膜功能并改善患者的预后。微创手术的进步以及人们对早期瓣膜疾病干预意识的提高推动了这种日益增长的临床需求，并正在推动市场扩张。技术创新持续推动市场成长。正如爱思唯尔公司 (Elsevier Inc.) 于 2023 年 8 月发表的一篇论文所强调的那样，球囊主动脉瓣瓣环成形(BAV) 的最新进展显着提升了其临床价值，尤其是在作为经导管主动脉瓣置换术术 (TAVR) 前的过渡治疗时。

在过去的二十年中，球囊导管技术取得了显着进展，终端使用者和设计方面的改进也有助于提高手术成功率。此外，心室起搏技术和动脉通路方法（例如增强经皮经皮股动脉通路）的改进降低了球囊导管（BAV）的相关风险，使手术更加安全可靠。这些技术突破重新点燃了人们对球囊导管（BAV）的兴趣，尤其是将其作为不适用于TAVR的患者的短期治疗选择。

技术进步提高了球囊主动脉瓣瓣环成形(BAV) 的可行性，临床医生也越来越熟练地操作大直径球囊并管理整个手术流程。球囊导管设计精度的提升和现代影像工具的进步改善了手术效果。然而，关于 BAV 的长期疗效仍然存在疑问，尤其是在经导管主动脉瓣置换术(TAVR) 不断取得成功的情况下，人们对该手术在现代治疗策略中的作用提出了质疑。

法规透过维护安全性、有效性和品质标准，在塑造美国市场方面发挥关键作用。虽然严格的监管标准可能会减缓核准流程、延迟产品上市并抑制创新，但它们也能增强病患信心并稳定设备效能。从长远来看，这些法规确保只有经过充分测试、可靠的设备才能核准用于临床，以支持市场成长。

目录

第一章调查方法与范围

第二章执行摘要

第三章美国瓣环成形设备市场变数、趋势与范围

• 市场体系展望
  • 母市场展望
  • 相关/附随市场展望
• 市场动态
  • 市场驱动因素分析
  • 市场限制因素分析
• 美国球囊瓣环成形术器械市场的分析工具
  • 产业分析-波特五力分析
  • PESTEL分析

第四章美国瓣环成形术设备市场：按应用的估计和趋势分析

• 按用途细分仪表板
• 美国瓣环成形术器械市场：按应用进行的变化分析
• 美国球囊瓣环成形术器械市场规模及应用趋势分析（2021-2033）
• 主动脉瓣狭窄
• 肺动脉狭窄

第五章美国瓣环成形术设备市场：依最终用途的估计和趋势分析

• 依最终用途细分仪表板
• 美国瓣环成形术器械市场：依最终用途进行的变化分析
• 美国球囊瓣环成形术器械市场规模及应用趋势分析（2021-2033）
• 医院
• 门诊手术中心（ASC）
• 心导管实验室

第六章 竞争态势

• 主要市场参与企业的近期趋势和影响分析
• 公司/竞争对手分类
• 2024年公司市场占有率分析
• 公司简介/上市公司
  • B. Braun Interventional Systems, Inc
  • BD
  • Edwards Lifesciences Corporation
  • Boston Scientific Corporation
  • Getinge
  • TORAY INTERNATIONAL, INC.
  • Stryker
  • BrosMed Medical Co., Ltd.
  • Medtronic
  • Terumo Corporation

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

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

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