Johnson & Johnson Advances the Standard of Calcium Modification With Global Launch of Shockwave™ C2 Aero Coronary IVL Catheter
- 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.-- Johnson & Johnson announced 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.
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, MD, PhD, 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, MD, 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.
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1 Compared to Shockwave C2+ in simulated use bench testing. Based on feedback from physicians who participated in the Limited Market Release Survey |
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2 Designed with more tapered tip and new hydrophilic coating compared to Shockwave C2+ |
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3 Designed with more flexible material compared to Shockwave C2+ |
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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. |
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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. |
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6 https://www.jacc.org/doi/10.1016/S0735-1097%2824%2904310-9 |
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7 Dr. Margaret McEntegart is a paid consultant for Shockwave Medical. She has not been compensated in connection with this press release. |
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8 Dr. Benjamin Honton is a paid consultant for Shockwave Medical. He has not been compensated in connection with this press release. |
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