J&J Debuts its Shockwave C2 Aero Coronary IVL Catheter

Johnson & Johnson today initiated the global launch of its Shockwave C2 Aero Coronary IVL Catheter designed for improved deliverability, enhanced lesion crossing, and new repositioning capabilities for calcified coronary artery disease (CAD) treatment.^1,2,3 The next-generation coronary intravascular lithotripsy (IVL) catheter leverages Shockwave IVL’s mechanism of action and the safety and effectiveness profile of its legacy catheters, expanding the company’s IVL portfolio.

CAD is the leading cause of death globally, affecting an estimated 315 million people worldwide and approximately one in 20 U.S. adults older than 20.^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, torturous 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., an interventional cardiologist at Clinique Pasteur in 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 of 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 clinical validation of our 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.

Part of Johnson & Johnson, Shockwave Medical Inc. develops and commercializes products for cardiovascular disease treatment. Its first-of-its-kind Intravascular Lithotripsy (IVL) technology has transformed atherosclerotic cardiovascular disease treatment 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 patients suffering from refractory angina by redistributing blood flow within the heart.

Johnson & Johnson’s cardiovascular portfolio provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation to address conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. The company considers itself a global leader in heart recovery, circulatory restoration, and heart rhythm disorders treatment, as well as an emerging leader in neurovascular care.

Johnson & Johnson is striving to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through its expertise in Innovative Medicine and MedTech, Johnson & Johnson delivers the breakthroughs of tomorrow and impacts health for humanity.

References
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.