U.S. Guidewires Market (2025 - 2033) Size, Share & Trends Analysis By Product (Coronary Guidewires, Peripheral Guidewires, Urology Guidewires, Neurovascular Guidewires), And Segment Forecasts

U.S. Guidewires Market Summary

Moreover, a growing number of minimally invasive surgeries, paired with a rising geriatric population, presents an opportunity for increased product demand. Factors such as a rising number of coronary & peripheral intervention procedures and an increase in the geriatric population are resulting in high demand for minimally invasive surgeries in the country. This is expected to have a positive impact on the market in the years to come. A majority of people in the U.S. are inclined towards noninvasive surgeries owing to the probability of high infection associated with invasive procedures. According to data published by Yale Medicine, approximately 900,000 percutaneous coronary interventions (PCIs) are performed in the U.S. every year. Thus, such a high procedural volume is anticipated to support the nationwide demand for guidewires.

Moreover, the rising number of clinical trials and research studies aimed at expanding the applications of guidewires is expected to significantly support the country’s market growth. These trials are increasingly focused on assessing the safety and efficacy of guidewires across various procedures, as well as accelerating the development of novel and advanced products. Research institutions, academic centers, and industry players are actively collaborating on these investigations. Favorable clinical outcomes validate product performance, facilitating regulatory approvals, enhancing clinician adoption, and contributing to broader market expansion.

Some of the ongoing clinical trials are outlined below

Source: ClinicalTrials.gov

Technological advancements and the introduction of innovative products that enhance procedural safety, efficiency, and cost-effectiveness are key drivers of market growth. For example, in April 2024, Teleflex Incorporated launched the Wattson Temporary Pacing Guidewire, initially introduced at Columbia University Irving Medical Center. Designed to streamline workflows, the device supports both valve delivery and ventricular bipolar pacing in structural heart procedures such as balloon aortic valvuloplasty (BAV) and transcatheter aortic valve replacement (TAVR). Its flexible distal pigtail and multi-electrode bipolar configuration help reduce the risk of ventricular perforation while ensuring reliable, rapid pacing. Such advancements, along with growing adoption among clinicians, are expected to further propel the expansion of the U.S. guidewires industry.

“We are thrilled that our team at Columbia University Irving Medical Center was selected for the Wattson Temporary Pacing Guidewire limited market release and are proud to have completed the first TAVR procedures with this important new device. The Wattson Temporary Pacing Guidewire facilitated minimalist TAVR procedures with safe and reliable LV pacing throughout our first two days of cases, and we are eager to continue to use it moving forward.”said Dr. Tamim Nazif, Director of Clinical Research for Columbia Interventional Cardiovascular Care, Director of the Interventional Cardiology Fellowship Program, and assistant professor in medicine at Columbia University Irving Medical Center.

Market Concentration & Characteristics

The market growth stage is moderate, with an accelerating pace of growth. The U.S. guidewires market is characterized by moderate growth due to the rising burden of chronic diseases, supportive government and regulatory initiatives, and the growing research activities.

Industry players, researchers, and academic institutions are actively working to advance guidewire technologies for use in a wide range of surgical procedures. Efforts include exploring new coating materials and integrating cutting-edge technologies to enhance performance and safety. For example, in October 2024, researchers at the Georgia Institute of Technology unveiled the smallest robotic guidewire, the Coaxially Aligned Steerable Guidewire Robot (COAST). This remotely controlled device enhances navigational precision within complex vascular pathways and reduces procedural risks due to its micro-tendon actuation system, which enables smooth, kink-free movement. Such technological innovations are expected to significantly support market growth.

The U.S. Food and Drug Administration (FDA) regulates guidewires as medical devices under regulation number 870.1330. Classified as Class II devices, they require appropriate premarket oversight, which is managed by the Office of Neurological and Physical Medicine Devices.

Industry players in the guidewires market are increasingly entering distribution collaborations to enhance product visibility, broaden market reach, and strengthen their presence in the U.S. For example, in July 2025, Medtronic announced an exclusive U.S. distribution collaboration with Future Medical Design Co., Ltd. (FMD), a Japan-based company, to market FMD’s workhorse and specialty peripheral guidewires. The arrangement expands Medtronic’s portfolio for transradial access in the treatment of peripheral artery disease. Under the agreement, Medtronic becomes the sole distributor of selected peripheral stainless-steel guidewires.

Product Insights

The coronary guidewires segment dominated the U.S. guidewires industry, accounting for 42.77% of the total revenue in 2024. This dominance is attributable to high usage rates and increasing preference for minimally invasive coronary procedures. Increased public awareness of cardiovascular diseases and minimally invasive treatment options will likely lead to more people seeking these procedures, thereby increasing demand for coronary guidewires. Continuous technological advancements and increasing healthcare accessibility are expected to drive a larger market share for the coronary guidewire segment over the forecast period.

The neurovascular guidewires segment is expected to register the fastest CAGR over the forecast period, driven by increasing industry efforts to develop advanced solutions for neurovascular procedures and supportive regulatory pathways. For example, in May 2023, Artiria Medical, based in Switzerland, received 510(k) clearance from the U.S. FDA for its real-time, deflectable neurovascular guidewire. The device provides enhanced navigation within the brain’s complex arterial network by allowing physicians to shape the distal tip in real time without removing it from the patient, while also enabling adjustments to the wire’s support profile throughout the procedure. Such regulatory approvals are anticipated to further accelerate segment growth.

“We are excited about receiving the FDA clearance on a cutting-edge, Swiss-made technology. We are looking forward to starting our clinical activities in the U.S. very soon.” Said Guillaume Petit-Pierre, co-founder and CEO of Artiria.

Key U.S. Guidewires Company Insights

Market participants are advancing product offerings, prioritizing regulatory clearances, and enhancing growth opportunities through strategic partnerships and collaborative initiatives.

Recent Developments

• In October 2024, researchers at the Georgia Institute of Technology unveiled the smallest robotic guidewire, the Coaxially Aligned Steerable Guidewire Robot (COAST). This remotely controlled device enhances navigational precision within complex vascular pathways and reduces procedural risks due to its micro-tendon actuation system, which enables smooth, kink-free movement.

• In October 2024, In October 2024, Baylis Medical Technologies announced the U.S. commercial launch of the PowerWire Pulse radiofrequency (RF) guidewire. As the latest addition to the PowerWire family, this 0.035-inch RF guidewire is designed to create a controlled pathway through soft tissues using precision RF puncture technology. It features a torquable, stiff proximal shaft for enhanced control and a smooth transition to a flexible distal tip for safe navigation in complex anatomies. The PowerWire Pulse has been utilized across multiple clinical applications, including soft-tissue cutting within the cardiovascular, portal venous, biliary, urinary, and gastrointestinal systems.

• In September 2024, Philips announced FDA approval for its enhanced LumiGuide guidewire, coinciding with the milestone of treating the 1,000th patient using its breakthrough 3D device-guidance technology. The updated, longer LumiGuide Navigation Wire now allows U.S. clinicians to visualize a wider range of catheters, further advancing procedural precision. This achievement also marks the 1,000th procedure supported by Philips’ Fiber Optic RealShape (FORS) technology, underscoring its growing adoption in clinical practice.

• In April 2024, Teleflex Incorporated launched the Wattson Temporary Pacing Guidewire, initially introduced at Columbia University Irving Medical Center. Designed to streamline workflows, the device supports both valve delivery and ventricular bipolar pacing in structural heart procedures such as balloon aortic valvuloplasty (BAV) and transcatheter aortic valve replacement (TAVR). Its flexible distal pigtail and multi-electrode bipolar configuration help reduce the risk of ventricular perforation while ensuring reliable, rapid pacing.

U.S. Guidewires Market Report Scope

U.S. Guidewires Market Report Segmentation

This report forecasts revenue growth at the country level 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. guidewires market report based on product:

• Product Outlook (Revenue, USD Million, 2021 - 2033)

  • Coronary Guidewires

  • Peripheral Guidewires

  • Urology Guidewires

  • Neurovascular Guidewires