Johnson & Johnson Advances the Standard of Calcium Modification with Global Launch of Shockwave™ C2 Aero Coronary IVL Catheter

Key Terms

intravascular lithotripsy medical

A catheter-based procedure that uses short pulses of sonic pressure waves delivered inside blood vessels to crack and soften hard calcium deposits that narrow arteries, much like using controlled pebbles to chip away a stubborn rock clog in a pipe. Investors care because the technology can make minimally invasive artery treatments safer and more effective, potentially increasing procedure volumes, device sales, hospital adoption and reimbursement, which affect medical-device company revenues and healthcare costs.

coronary artery disease medical

Coronary artery disease is a condition in which the blood vessels that supply the heart become narrowed or blocked by fatty buildup, reducing oxygen-rich blood flow and making the heart work harder. For investors, it matters because the condition drives demand for medications, medical devices, diagnostics and procedures, can affect healthcare spending and payer policies, and influences the financial prospects of companies involved in cardiovascular care—similar to how a clogged pipe changes maintenance and replacement needs.

calcified coronary lesions medical

Calcified coronary lesions are areas in the heart’s arteries where hard calcium buildup has formed, narrowing or stiffening the vessel so blood can’t flow as easily. Think of them like mineral scale clogging a water pipe: they are tougher to treat than softer blockages and often require specialized devices or procedures, which affects medical costs, procedure risks and the market demand for specific treatments—important signals for investors assessing healthcare companies.

percutaneous coronary intervention medical

A minimally invasive heart procedure that opens narrowed or blocked coronary arteries by threading a thin tube from a wrist or groin to the heart and using a balloon and usually a small metal scaffold (stent) to restore blood flow. Investors care because the procedure drives sales and regulatory exposure for device makers, hospitals and suppliers, and influences healthcare costs and insurance payments—think of it like a plumbing repair that requires parts, skilled labor and follow-up maintenance.

multivessel disease medical

Multivessel disease is a heart condition where blockages or severe narrowing occur in more than one of the main arteries that supply blood to the heart, like several major roads in a city being partly closed. It matters to investors because it typically leads to more complex, costly and riskier medical care—shaping demand for surgeries, devices, drugs and long‑term treatment costs, which can affect hospitals’, device makers’ and insurers’ revenues and risk profiles.

hydrophilic coating technical

A hydrophilic coating is a thin surface layer applied to medical devices that soaks up and holds a thin film of water, making the device feel slippery and reducing friction against tissue—like wetting a ski to glide over snow. For investors, the presence, quality and regulatory acceptance of such coatings matter because they can improve device performance, patient outcomes, marketability and reimbursement, while also affecting manufacturing costs and regulatory or liability risk.

ultrasonic acoustic pressure waves medical

High-frequency sound pulses above the range humans can hear that travel through air or tissue as tiny pressure ripples. In medical and industrial devices they are used for imaging, targeted therapy, cleaning or moving tiny particles—think of them like invisible, very fast ripples that can probe or push things without cutting. Investors care because these waves determine a product’s effectiveness, safety, regulatory approval and market potential, affecting revenue and risk.

balloon repositioning technical

Balloon repositioning is the controlled movement of an inflatable catheter tip inside a blood vessel or body cavity to a new location during a minimally invasive procedure, similar to sliding and re-centering a small deflated balloon on a string until it sits over the exact spot that needs treatment. Investors care because the maneuver affects procedure success, device design, and procedure time — factors that influence clinical outcomes, reimbursement rates, product demand and regulatory scrutiny for medical-device makers.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

• Next-generation intravascular lithotripsy (IVL) catheter resets physicians’ expectations by addressing unmet needs in deliverability, lesion crossing and balloon repositioning
• Shockwave C2 Aero enables clinicians to extend Shockwave IVL’s clinically-validated mechanism of action to a broader spectrum of calcified coronary lesions

SANTA CLARA, Calif.--(BUSINESS WIRE)-- Johnson & Johnson (NYSE: JNJ) announced today the global launch of its Shockwave C2 Aero Coronary IVL Catheter designed for improved deliverability, enhanced lesion crossing and new repositioning capabilities for the treatment of calcified coronary artery disease (CAD).^1,2,3 The next-generation coronary IVL catheter leverages Shockwave IVL’s unique mechanism of action and the safety and effectiveness profile of its legacy catheters, expanding the company’s market-leading IVL portfolio.

Shockwave C2 Aero, a next generation coronary IVL catheter addresses unmet needs in deliverability, lesion crossing, and balloon repositioning.

CAD is the leading cause of death globally, affecting an estimated 315 million people worldwide and approximately 1 in 20 adults over the age of 20 in the U.S.^4,5,6 In CAD, progressive buildup of cholesterol deposits gradually narrows the vessels, reducing blood flow to the heart muscle and leading to chest pain (angina) and heart attacks. Over time, cholesterol deposits may accumulate calcium and harden, making them difficult to treat with conventional techniques. Further challenges arise in cases with tortuous arteries and severe calcification, which can prevent modification tools from navigating and crossing the lesion.

“Shockwave C2 Aero makes it easier to navigate tortuous coronary anatomy without relying on additional upfront ancillary devices. That enhanced deliverability and efficiency can change IVL use and expand its role in treatment algorithms,” said Margaret McEntegart, M.D., Ph.D., Director of Complex Percutaneous Coronary Intervention Program at Columbia University Medical Center/New York-Presbyterian Hospital.⁷ “By continuing to address real unmet physician needs like deliverability, crossability and repositioning, Johnson & Johnson is pushing expectations for what the technology can achieve in complex PCI procedures.”

Shockwave C2 Aero provides physicians with greater flexibility and efficiency in treatment strategy by:¹

• Enhancing deliverability through tight, tortuous arteries via more flexible shaft, balloon and marker bands. ¹
• Easing entry and crossing of dense calcified deposits with its tapered tip and new hydrophilic coating. ²
• Allowing repositioning within the coronary anatomy to treat additional lesions due to the new balloon material designed for more compact deflation. ³

“In earlier iterations of the technology, physicians often had to rely on additional ancillary devices to achieve optimal positioning, and treatment was generally limited to a distal-to-proximal approach in coronary lesions,” said Benjamin Honton, M.D., Interventional Cardiologist at Clinique Pasteur, Toulouse, France.⁸ “The balloon rewrap capability of the Shockwave C2 Aero enables easier repositioning, allowing both proximal and distal movement within the vessel, as well as lesion recrossing when needed. This added flexibility facilitates the treatment of more complex patterns of calcification and supports more tailored pulse delivery strategies, including in multivessel disease, expanding what can be achieved with intravascular lithotripsy.”

Shockwave C2 Aero has a working length of 138 centimeters and features two emitters encased in an integrated balloon that fire simultaneously up to 120 pulses, delivering up to 240 Shockwaves. Each Shockwave pulse creates ultrasonic acoustic pressure waves that pass through soft tissue and crack hardened calcium in place, helping to re-establish blood flow in the blocked artery.

“We’re redefining standards for coronary IVL with more efficient and predictable overall procedures in challenging cases when it matters most,” said Isaac Zacharias, President, Shockwave Medical, MedTech, Johnson & Johnson. “As others prepare to enter the coronary IVL market, Johnson & Johnson is raising the bar with our fifth-generation platform built on years of physician feedback, sustained R&D advancements and robust clinical validation of our unique mechanism of action that reinforce our IVL leadership.”

Shockwave C2 Aero is now available in the United States and Japan and will be available in Europe and Canada in the coming months. The next-generation coronary IVL technology will be featured in the booth from Shockwave Medical, part of Johnson & Johnson, at EuroPCR 2026 taking place in Paris, France from May 19-22, 2026.

About Shockwave Medical
Shockwave Medical Inc., part of Johnson & Johnson, is a leader in the development and commercialization of innovative products that are transforming the treatment of cardiovascular disease. Its first-of-its-kind Intravascular Lithotripsy (IVL) technology has transformed the treatment of atherosclerotic cardiovascular disease by safely using ultrasonic acoustic pressure waves to disrupt challenging calcified plaque, resulting in significantly improved patient outcomes. Its Reducer technology, which is under clinical investigation in the United States and is CE Marked in the European Union and the United Kingdom, is designed to provide relief to the millions of patients worldwide suffering from refractory angina by redistributing blood flow within the heart. Learn more at www.shockwavemedical.com.

About Cardiovascular Solutions from Johnson & Johnson
Across Johnson & Johnson, we are tackling the world’s most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation, we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke.

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.

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to Shockwave C2 Aero Coronary IVL Catheter. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

______________________________

1 Compared to Shockwave C2+ in simulated use bench testing. Based on feedback from physicians who participated in the Limited Market Release Survey

2 Designed with more tapered tip and new hydrophilic coating compared to Shockwave C2+

3 Designed with more flexible material compared to Shockwave C2+

4 Centers for Disease Control and Prevention. About Coronary Artery Disease (CAD). https://www.cdc.gov/heart-disease/about/coronary-artery-disease.html. Last Accessed: March 24, 2025.

5 Centers for Disease Control and Prevention. Heart Disease Facts. https://www.cdc.gov/heart-disease/data-research/facts-stats/index.html. Last Accessed: March 24, 2025.

6 https://www.jacc.org/doi/10.1016/S0735-1097%2824%2904310-9

7 Dr. Margaret McEntegart is a paid consultant for Shockwave Medical. She has not been compensated in connection with this press release.

8 Dr. Benjamin Honton is a paid consultant for Shockwave Medical. He has not been compensated in connection with this press release.

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20260512562027/en/

Media Contact:
Rachael Jarnagin
rjarnagi@its.jnj.com

Erin Farley
efarley1@its.jnj.com

Investor Contact:
Investor-relations@its.jnj.com

Source: Johnson & Johnson