Johnson & Johnson (NYSE:JNJ) today announced the global launch of the Shockwave C2 Aero coronary intravascular lithotripsy (IVL) catheter.
The next-generation catheter leverages Shockwave IVL’s unique mechanism of action and the safety and effectiveness profile of its legacy catheters. It features improved deliverability, enhanced lesion crossing and new repositioning capabilities. The coronary catheter expands the company’s market-leading IVL portfolio for treating calcified coronary artery disease (CAD).
Johnson & Johnson said that Shockwave C2 Aero provides physicians with greater flexibility and efficiency in treatment strategy. It enhances deliverability through tight, tortuous arteries via a more flexible shaft, balloon and marker bands. The catheter also enables ease of entry and crossing of dense calcified deposits with its tapered tip and new hydrophilic coating.
Repositioning within the coronary anatomy is made possible to treat additional lesions, thanks to new balloon material designed for more compact deflation.
The catheter has a working length of 138 cm. It features two emitters encased in an integrated balloon that fire simultaneously up to 120 pulses, making up to 240 “Shockwaves.” Each Shockwave pulse creates ultrasonic acoustic pressure waves that pass through soft tissue and crack hardened calcium in place. This helps to re-establish blood flow in the blocked artery.
J&J said it now offers Shockwave C2 Aero in the U.S. and Japan. It expects to bring the catheter to Europe and Canada in the coming months. The launch comes as the IVL space, led by J&J since its $13.3 billion acquisition of Shockwave in 2024, continues to heat up. Stryker just completed an acquisition of Amplitude Vascular Systems last week, while Boston Scientific acquired Bolt Medical last year.
Abbott also has its own IVL system in the works, while FastWave Medical, Elixir Medical and Vantis Vascular advance their own platforms.
Commentary from Johnson & Johnson officials and users of Shockwave IVL
Isaac Zacharias, president, Shockwave Medical, MedTech, Johnson & Johnson, said:
“We’re redefining standards for coronary IVL with more efficient and predictable overall procedures in challenging cases when it matters most. 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.”
Dr. Benjamin Honton, interventional cardiologist at Clinique Pasteur (Toulouse, France) said:
“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. 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.”
Dr. Margaret McEntegart, director of the Complex Percutaneous Coronary Intervention Program at Columbia University Medical Center/New York-Presbyterian Hospital, said:
“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. 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.”
