Johnson & Johnson Launches Shockwave C2 Aero Fly Coronary IVL Catheter to Cut Treatment Time in Half
Johnson & Johnson (NYSE: JNJ) has announced the U.S. launch of its Shockwave C2 Aero Fly Coronary Intravascular Lithotripsy (IVL) Catheter, a next-generation device designed to treat a broad range of calcified coronary artery lesions in half the treatment time required by previous-generation coronary IVL devices. The launch represents another step in the company’s efforts to improve procedural efficiency and support physicians treating complex coronary artery disease.
The new catheter builds on the established Shockwave IVL technology and incorporates improvements introduced with the Shockwave C2 Aero platform. By delivering pulses at twice the previous rate and reducing the pause between pulsing cycles by 50%, Shockwave C2 Aero Fly is designed to shorten treatment time while maintaining the safety and effectiveness associated with earlier-generation catheters.¹˒³˒⁴
The device is intended to help interventional cardiologists manage calcified coronary lesions more efficiently, particularly as hospitals face growing procedural volumes and increasing complexity in cardiovascular care. Johnson & Johnson says the catheter combines faster pulse delivery with shorter balloon inflation periods and established delivery, lesion-crossing and repositioning capabilities.
“Shockwave C2 Aero Fly is built for the future of coronary interventions, where physicians need proven technologies that can help them move faster without compromising safety or confidence in challenging calcified cases,” said Mike Lang, Worldwide President, Circulatory Restoration, MedTech, Johnson & Johnson. “As the pioneer and leader of the category, Johnson & Johnson is giving physicians and patients an increasingly efficient, predictable platform designed to meet the growing demands of complex coronary care.”
Shockwave C2 Aero Fly is now available in the United States. Johnson & Johnson MedTech plans to feature the technology at its Circulatory Restoration booth during Transcatheter Cardiovascular Therapeutics (TCT) 2026, scheduled for October 31 through November 3 in San Diego, California.
Addressing the Growing Burden of Coronary Artery Disease
Coronary artery disease (CAD) remains a major global health challenge and a leading cause of death worldwide. The condition develops when the coronary arteries, which supply oxygen-rich blood to the heart muscle, become narrowed or obstructed. Atherosclerotic plaque can accumulate inside the arterial walls, restricting blood flow and increasing the risk of serious cardiovascular events.
Calcification can make coronary artery disease particularly difficult to treat. When calcium accumulates within arterial plaque, the affected vessels may become rigid and resistant to conventional balloon angioplasty. These lesions can complicate the delivery and expansion of coronary stents, potentially making it more difficult for physicians to achieve the desired vessel opening.
Coronary interventions are frequently used to restore blood flow in patients with significant arterial narrowing. However, heavily calcified lesions can require additional preparation before a stent can be implanted effectively. Physicians must balance the need to modify resistant calcium with the need to minimize procedural complications and avoid unnecessary delays during treatment.
The scale of the disease highlights the importance of improving available treatment approaches. According to figures cited by Johnson & Johnson, CAD affects an estimated 315 million people worldwide and approximately one in 20 U.S. adults over the age of 20.⁵˒⁶˒⁷ The company also points to the anticipated growth in cardiovascular disease prevalence and the high volume of coronary interventions performed in hospitals as reasons that efficiency in cardiac catheterization laboratories is increasingly important.⁸˒⁹
Cardiac catheterization laboratories, commonly called cath labs, are specialized clinical environments where physicians perform minimally invasive procedures to diagnose and treat cardiovascular conditions. As demand rises, hospitals must manage complex cases while making effective use of procedural time, clinical staff and equipment.
Reducing treatment time for individual procedures may help support these demands. In calcified coronary interventions, where lesion preparation can involve multiple treatment cycles, improvements in the speed of energy delivery and the intervals between cycles may be especially valuable.
How Shockwave Intravascular Lithotripsy Works
Shockwave IVL is designed to modify calcified plaque using sonic pressure waves delivered from a balloon-based catheter positioned within the affected coronary artery. The catheter is advanced to the target lesion, where the balloon is inflated and the system delivers pulses intended to fracture both superficial and deeper calcium within the vessel wall.
The goal is to make rigid, calcified lesions more compliant, allowing the vessel to expand more effectively during subsequent balloon dilation and stent placement. By modifying calcium, IVL can help physicians prepare difficult lesions without relying solely on mechanical approaches that may be less suitable for certain patterns of calcification.
The Shockwave C2 Aero Fly system builds on this established mechanism of action. Rather than introducing a completely different treatment approach, the new catheter focuses on improving the pace of pulse delivery and reducing the time required between treatment cycles.
These changes are intended to make the procedure more efficient while preserving the fundamental treatment approach used in previous-generation Shockwave coronary IVL devices. The company states that the next-generation catheter maintains the safety and effectiveness of earlier devices, although the specific comparative evidence supporting those claims should be assessed in the context of the underlying clinical data.¹˒³˒⁴
Faster Pulsing and Shorter Treatment Cycles
One of the principal features of Shockwave C2 Aero Fly is its increased pulse delivery rate. The catheter delivers pulses at a frequency of 2 hertz, or two pulses per second, allowing the treatment sequence to be completed more quickly than with previous-generation IVL catheters.
According to Johnson & Johnson, the change reduces the treatment time associated with pulse delivery from approximately 230 seconds to 115 seconds.¹ This represents a 50% reduction in the stated treatment time.
The device also shortens the pause between pulsing cycles. The interval has been reduced to five seconds, representing a 50% decrease compared with previous-generation devices.¹ Shorter intervals allow physicians to proceed through treatment cycles with less waiting, contributing to a more streamlined workflow.
Together, the faster pulse rate and shorter pauses are designed to reduce the time needed to deliver IVL treatment. This may be particularly relevant when physicians are managing complex calcified lesions that require careful preparation before further intervention.
Hector Tamez Aguilar, M.D., an interventional cardiologist at Piedmont Healthcare in Atlanta, Georgia, highlighted the importance of these workflow improvements.
“In the cath lab, every second matters, especially as we see more complex cases and higher procedure volumes,” said Dr. Tamez Aguilar. “By delivering pulses twice as fast and decreasing pause time between cycles, Shockwave C2 Aero Fly enables faster workflows, helping physicians treat calcified coronary disease more efficiently while meeting the growing pace and demand of cath labs.”
The ability to complete treatment more quickly may help clinicians manage time-sensitive procedures and improve the flow of work within busy catheterization laboratories. However, the overall effect on procedure duration will depend on the complexity of the lesion, the patient’s condition and the other steps required during the intervention. The stated 115-second figure refers to the specified IVL treatment time, rather than the duration of an entire coronary procedure.
Reducing Balloon Inflation and Patient Ischemic Time
Another important consideration in coronary IVL is the amount of time the balloon remains inflated during treatment. Balloon inflation temporarily restricts blood flow through the treated section of the coronary artery. As a result, reducing inflation time may help limit the period during which blood flow is interrupted.
Johnson & Johnson says the faster pulsing and shorter treatment intervals of Shockwave C2 Aero Fly can reduce balloon inflation time and, in turn, minimize temporary procedure-related blood flow blockage.² The company identifies this as a potential benefit for patients who experience ischemic symptoms, including chest discomfort, during coronary intervention.
Ischemia occurs when a tissue receives insufficient blood flow and oxygen. In coronary procedures, temporary interruption of blood flow can contribute to symptoms and requires careful management by the clinical team. The significance of any reduction in ischemic time depends on individual patient characteristics, lesion location and the procedural circumstances.
Karim Al-Azizi, M.D., Medical Director of the Structural Heart Program and Cardiac Catheterization Laboratories at Baylor Scott & White Health in Plano, Texas, emphasized the clinical relevance of shorter balloon inflation and pause times.
“During IVL treatment, balloon inflation temporarily blocks blood flow, and that time matters for patient care,” said Dr. Al-Azizi. “Shockwave C2 Aero Fly raises the bar for coronary interventions by making procedures easier for physicians and less strenuous for patients. Its shorter balloon inflation and pause time reduce ischemic time and related symptoms for patients, enabling better, quicker and more streamlined care.”
The design is intended to address both physician workflow and the patient experience. By shortening the period required for pulse delivery and reducing pauses between cycles, the catheter may help clinicians perform IVL treatment with less time spent on the inflation-related portion of the procedure.
These potential advantages should be interpreted in the context of the available clinical evidence. Shorter treatment cycles and reduced balloon inflation time are procedural features; their effects on patient outcomes, symptoms and recovery depend on clinical circumstances and require appropriate evaluation.
Building on Shockwave C2 Aero’s Delivery and Repositioning Capabilities
In addition to its faster pulse delivery, Shockwave C2 Aero Fly builds on the deliverability, crossability and repositioning features of the Shockwave C2 Aero platform.³ These capabilities are important when treating complex coronary lesions, which may be difficult to access or cross with a catheter.
Deliverability refers to the ability to navigate a device through the coronary anatomy and position it at the intended treatment site. Crossability describes the ability of the catheter to pass through a narrowed or otherwise challenging lesion. Repositioning allows physicians to adjust the device’s location when necessary to ensure that the intended area is treated.
In coronary interventions, these characteristics can influence how effectively a device reaches the target lesion and how easily clinicians can manage the treatment sequence. Calcified lesions may present particular challenges because the narrowed vessel can limit the passage of interventional equipment.
By retaining the established platform’s delivery and positioning features while increasing treatment speed, Shockwave C2 Aero Fly is designed to combine procedural familiarity with greater efficiency. Johnson & Johnson describes these capabilities as part of the catheter’s leading performance characteristics.³
The combination may be relevant for physicians treating a broad range of calcified coronary artery lesions, particularly where effective lesion preparation and predictable catheter handling are essential components of the procedure.
Supporting More Efficient Cath Lab Workflows
The introduction of Shockwave C2 Aero Fly comes as cardiovascular care providers seek ways to manage growing demand without compromising the quality of treatment. Hospitals must coordinate clinicians, equipment and procedural resources while responding to an increasingly complex patient population.
Coronary interventions often involve multiple steps, including vascular access, catheter navigation, lesion assessment, plaque preparation, balloon dilation and stent deployment where indicated. The time required for each step varies depending on the anatomy, the extent of calcification and the patient’s clinical condition.
Technologies that reduce the duration of specific procedural tasks may help make workflows more predictable. In the case of coronary IVL, faster pulse delivery and shorter intervals between cycles are intended to reduce the time associated with delivering treatment to calcified lesions.
The potential operational benefits do not necessarily mean that every procedure will be shorter by the same amount. Individual treatment times may vary, and overall efficiency depends on several clinical and logistical factors. Nevertheless, the device’s design addresses a practical challenge for interventional cardiologists: how to perform complex coronary interventions effectively while managing limited procedural time.
For patients, reduced balloon inflation time may also be meaningful because it can shorten the period of temporary blood-flow interruption associated with IVL treatment. The extent to which this translates into measurable improvements in comfort or clinical outcomes will depend on the patient’s condition and the evidence available from clinical use.
Johnson & Johnson’s Broader Cardiovascular Strategy
Shockwave C2 Aero Fly forms part of Johnson & Johnson’s broader cardiovascular portfolio, which includes technologies intended to address conditions associated with substantial disease burden and unmet medical needs.
The company’s cardiovascular activities span heart recovery, circulatory restoration and the treatment of heart rhythm disorders, alongside a growing focus on neurovascular care. Its portfolio includes technologies that support advanced mapping and navigation, miniaturized treatment approaches and precise ablation.
These areas address a range of serious conditions, including heart failure, coronary artery disease, peripheral artery disease, stroke and atrial fibrillation. Each presents different clinical challenges, but collectively they represent significant contributors to illness, disability and mortality worldwide.
Within this strategy, circulatory restoration focuses on technologies designed to help restore or improve blood flow in patients with vascular disease. Coronary IVL is one approach within this field, targeting the calcification that can complicate the treatment of narrowed coronary arteries.
The launch of Shockwave C2 Aero Fly reflects the company’s focus on refining established technologies to address procedural challenges. Its design emphasizes speed, shorter balloon inflation periods and established catheter handling capabilities, rather than changing the underlying IVL treatment mechanism.
For more information about Shockwave technologies and Johnson & Johnson’s circulatory restoration portfolio, visit the company’s Shockwave Medical website.
U.S. Availability and Upcoming TCT 2026 Showcase
Johnson & Johnson confirmed that Shockwave C2 Aero Fly is now available in the United States. The company will present the next-generation coronary IVL technology at its Circulatory Restoration booth during TCT 2026, taking place in San Diego, California, from October 31 to November 3, 2026.
The conference will provide an opportunity for the company to showcase the device to the cardiovascular intervention community as physicians and healthcare organizations continue to evaluate technologies for treating complex coronary disease.
With its faster pulse delivery, five-second pauses between cycles and stated reduction in IVL treatment time from 230 seconds to 115 seconds, Shockwave C2 Aero Fly is positioned as an efficiency-focused evolution of the coronary IVL platform.
As cardiovascular disease continues to place pressure on healthcare systems, devices that support effective treatment of calcified lesions may have an important role in procedural planning. The ultimate value of the technology will depend on its performance in clinical practice, its suitability for individual patients and the evidence supporting its safety and effectiveness.
Through the U.S. launch, Johnson & Johnson is expanding the availability of a coronary IVL catheter designed to help physicians manage calcified coronary artery disease with a faster treatment sequence while retaining key features of the previous-generation platform.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector’s global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at https://www.jnjmedtech.com/en-US/. Follow us at @JNJMedTech and on LinkedIn. Shockwave Medical, Inc. is a Johnson & Johnson company.