Johnson & Johnson launches next-generation coronary IVL catheter for calcified artery disease

Johnson & Johnson announced the global launch of the next-generation Shockwave C2 Aero Coronary Intravascular Lithotripsy, or IVL, catheter, designed to improve treatment of calcified coronary artery disease by enhancing deliverability, lesion crossing and repositioning capabilities during complex coronary procedures.

The company said the new catheter expands the Shockwave IVL portfolio and is intended to help physicians treat difficult coronary blockages involving severe calcification and tortuous anatomy. The technology is now available in the United States and Japan, with launches in Europe and Canada planned in the coming months.

Coronary artery disease remains the leading cause of death worldwide, affecting an estimated 315 million people globally, according to the company. The disease develops as cholesterol deposits narrow arteries and reduce blood flow to the heart. Over time, calcium can accumulate within the plaque, hardening the blockage and making treatment more challenging.

“Shockwave C2 Aero makes it easier to navigate tortuous coronary anatomy without relying on additional upfront ancillary devices,” said Margaret McEntegart, director of the Complex Percutaneous Coronary Intervention Program at Columbia University Medical Center/NewYork-Presbyterian Hospital. “That enhanced deliverability and efficiency can change IVL use and expand its role in treatment algorithms.”

Johnson & Johnson said the new catheter includes a more flexible shaft, balloon and marker bands to improve navigation through difficult anatomy. The device also features a tapered tip and hydrophilic coating designed to improve crossing of dense calcified lesions.

The company said a redesigned balloon material allows the catheter to deflate more compactly, enabling physicians to reposition the device within the artery to treat additional lesions.

“In earlier iterations of the technology, physicians often had to rely on additional ancillary devices to achieve optimal positioning,” said Benjamin Honton, an interventional cardiologist at Clinique Pasteur in Toulouse, France. “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.”

The Shockwave C2 Aero catheter has a working length of 138 centimeters and contains two emitters within an integrated balloon capable of delivering up to 240 shockwave pulses. The pulses generate ultrasonic acoustic pressure waves that pass through soft tissue and fracture hardened calcium deposits within the artery walls.

“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 at Johnson & Johnson MedTech.

Johnson & Johnson acquired Shockwave Medical as part of its cardiovascular technology portfolio focused on treating calcified vascular disease using intravascular lithotripsy technology.