The North America balloon catheters market size was valued at USD 1.44 Billion in 2025. It is expected to grow at a CAGR of 10.59% during the forecast period of 2026-2035, driven by the rising prevalence of cardiovascular diseases in the region. The market is estimated to reach a value of USD 3.94 Billion by 2035.
Base Year
Historical Period
Forecast Period
In December 2023 , the United States Food and Drug Administration (FDA) approved Summa Therapeutics’ Finesse Injectable angioplasty balloon catheters for the treatment of peripheral artery disease.
In December 2023 , an Exclusive Commercial Agreement was signed between HR Pharmaceuticals, Inc. (HRP) and Poiesis Medical LLC, which granted HRP the rights to commercialize Poiesis's Dual Balloon Catheter (Duette™) in North America.
In the United States , heart disease is the leading cause of mortality, with Centers for Disease Control and Prevention data reporting that one individual dies every 33 seconds from cardiovascular disease.
Compound Annual Growth Rate
10.59%
Value in USD Billion
2026-2035
*this image is indicative*
Balloon catheters have an inflatable balloon at the tip, which can enlarge a narrow opening in a catheterization procedure. The minimally invasive nature of the device is attracting high demand in the market for various medical interventions such as angioplasty and stenting. With a rising patient inclination towards minimally invasive procedures due to certain benefits including reduced surgical trauma and shortened recovery time, North America balloon catheters market demand is expected to witness a surge in the forecast period.
The market is experiencing improvement in the regulatory landscape which boosts the growth. Faster regulatory approvals not only enhance access to novel balloon catheter products but also increase their adoption rates in the healthcare sector. In December 2023, the United States Food and Drug Administration (FDA) approved the Finesse Injectable angioplasty balloon catheters developed by Summa Therapeutics, LLC (a United States-based medical devices company), for the percutaneous transluminal angioplasty (PTA) treatment of peripheral artery disease. The Finesse product line includes a port for injecting radiopaque contrast material coupled with its performance of balloon angioplasty, making it an advanced toolset for angioplasty procedures. The availability of such innovative products in healthcare settings is anticipated to propel North America balloon catheters market share in the forecast period.
In December 2023 , an Exclusive Commercial Agreement was signed between a medical equipment manufacturer in the United States, HR Pharmaceuticals, Inc. (HRP), and Poiesis Medical LLC (a medical device company in Florida). As per the terms of collaboration, HRP received the rights to commercialize Poiesis's Dual Balloon Catheter (Duette™) in North America. This Dual Balloon Catheter technology is designed for patients enduring prolonged catheterization and exhibits better results as compared to traditional Foley Catheters. The increased access to such innovative balloon catheter products to the rising patient population in the region is likely to fuel market growth. The rise in strategic partnerships among the key market players which support the market expansion of balloon catheter devices marks as one of the most significant North America balloon catheters market trends.
Other factors that drive the market value include the presence of advanced infrastructure. The growing elderly population more prone to cardiovascular diseases is also poised to directly affect the market demand. Further, the existence of several leading market players and premium research institutions positively impacts the market landscape.
“North America Balloon Catheters Market Report and Forecast 2026-2035” offers a detailed analysis of the market based on the following segments:
Market Breakup by Product Type
Market Breakup by Catheter Type
Market Breakup by Balloon Type
Market Breakup by Material
Market Breakup by Indication
Market Breakup by End User
Market Breakup by Region
The key features of the market report include patent analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:
Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.
North America Balloon Catheters Companies
Europe Balloon Catheters Market
Asia Pacific Balloon Catheters Market
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The market attained a value of about USD 1.44 Billion in 2025 driven by driven by the rising prevalence of cardiovascular diseases in the region.
The market is anticipated to grow at a CAGR of 10.59% during the forecast period of 2026-2035, likely to reach a market value of USD 3.94 Billion by 2035.
Advancements in balloon catheter technology and rising healthcare expenditure are fuelling the demand for the regional market.
One of the significant trends in the market is the rise in strategic partnerships among the key market players. In December 2023, HR Pharmaceuticals, Inc. (HRP) and Poiesis Medical LLC, signed an exclusive commercial agreement which granted HRP the rights to commercialize Poiesis's Dual Balloon Catheter (Duette™) in North America.
Based on the product type, the market is segmented into PTA balloon catheters, PTCA balloon catheters, occlusion balloon catheters, foley catheters, nephrostomy balloon catheters, drug-eluting catheters, normal balloon catheter, cutting balloon catheter, scoring balloon catheter, drug eluting balloon catheter, and stent graft balloon catheter, among others.
Based on the product type, the market is segmented into fixed wire, over-the-wire, and rapid exchange catheter.
Major end users include hospitals and specialty clinics, among others.
Based on the material, the market includes polyurethane, and nylon, among others.
Based on the balloon type, the market includes non-compliant, semi-compliant, and compliant catheters.
Based on indication, the market includes coronary artery disease and peripheral vascular disease.
The market segmentation by countries includes the United States of America and Canada.
The key market players are Abbott Laboratories, Becton Dickinson and Company, Boston Scientific Corporation, Bard Medical Division, B.Braun Melsungen AG, Johnson & Johnson, Teleflex Incorporated, Medtronic PLC, Edwards Lifesciences Corporation, and Vascular Solutions, Inc.
Explore our key highlights of the report and gain a concise overview of key findings, trends, and actionable insights that will empower your strategic decisions.
| REPORT FEATURES | DETAILS |
| Base Year | 2025 |
| Historical Period | 2019-2025 |
| Forecast Period | 2026-2035 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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| Breakup by Product Type |
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| Breakup by Catheter Type |
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| Breakup by Balloon Type |
|
| Breakup by Material |
|
| Breakup by Indication |
|
| Breakup by End User |
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| Breakup by Region |
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| Market Dynamics |
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| Supplier Landscape |
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| Companies Covered |
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