Shockwave Medical's new IVL catheter overcomes previous limitations

 

The newest coronary intravascular lithotripsy (IVL) catheter from Shockwave Medical, a Johnson & Johnson MedTech company, is officially here, and it was built to improve one of the technology’s biggest historical limitations: deliverability in a complex coronary anatomy.

In early May, Johnson & Johnson announced the official launch of the Shockwave C2 Aero Coronary IVL Catheter. To learn more about the new-look device, Cardiovascular Business spoke with Ziad Ali, MD, DPhil, director of the DeMatteis Cardiovascular Institute at St. Francis Hospital and Heart Center, about his center's early experience using it treat calcified coronary artery disease. Ali said his center was the first in the world to use the catheter in August 2025 and has since gained experience in roughly 80 cases.

“The Achilles' heel of IVL was its ability to deliver the catheter to get it into the lesions,” Ali explained. “It was considered to be a relatively inflexible device. Navigating tortuosity and getting it into calcified lesions was a challenge.”

The new Shockwave Medical catheter, however, dramatically improves flexibility and trackability, allowing operators to simplify procedures and reduce the need for additional support devices. Previous generations of IVL often required larger guide catheters, more supportive wires, buddy wires, guide extension catheters or femoral access to help advance the balloon across heavily calcified coronary lesions. Ali said this device largely eliminates those workflow adjustments.

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Among the key design changes is a new hydrophilic coating on the first 25 centimeters of the catheter shaft, which improves lubricity and allows the device to more easily cross tight or fibrotic lesions. The catheter itself is also significantly more flexible than earlier versions.

“The Aero is much, much more flexible. This was much more of a ‘holy cow’ situation where we used it for the first time and it is so much better,” Ali said.

The company also redesigned the positioning of the lithotripsy emitters within the balloon and added a tapered catheter tip to further improve deliverability. While the overall device profile remains unchanged, Ali said the combination of changes has transformed how he approaches calcified coronary interventions.

“I’ve completely switched my practice. I no longer use the big guides. I use the workhorse wire. I don’t open guide extension catheters. I use a really standard workflow now in IVL,” he explained.

The updated catheter may shorten treatment time by reducing the delay between lithotripsy pulses from 10 seconds to five seconds. The system delivers 120 pulses and 240 shockwaves through two emitters.

Wider IVL adoption is due to its increased safety

Ali said the rapid adoption of IVL over the past several years reflects growing physician confidence in the technology’s safety profile compared to atherectomy devices.

"In interventional cardiology, when efficacy is equal, there is one discriminator, which is safety. So if you have a tool that can do the same thing, but one of those tools is safer, you will always use that choice. It will always be best to do the safest possible tool," Ali explained.

Atherectomy, high pressure balloons and cutting balloons were used prior to IVL to use brute force or mechanical cutting to break or grind away the calcium. But these therapies can cause artery perforation, which made many interventional cardiologists shy away from using these technologies. Prior to IVL, calcium modification was done at about 8% of cases in the United States. However, IVL saw a rapid rise to about 15%, and atherectomy use dropped down to about 5%, Ali said.

“If there’s anything dreaded by the interventional cardiologist, it’s going to be a perforation,” he said. “If you take that off the table and you give them safety, it really liberates and democratizes calcium modification for interventional cardiologists globally.”

He emphasized that atherectomy and IVL serve different purposes in lesion preparation. Atherectomy devices are designed for plaque debulking, while IVL modifies calcium by fracturing calcified plaque within the vessel wall to improve stent expansion. Some operators also see these therapies as complementary. But the numbers show a definite preference for the safety and ease of use with IVL.

Dave Fornell is a digital editor with Cardiovascular Business and Radiology Business magazines. He has been covering healthcare for more than 16 years.

Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]

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