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

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