Shockwave had just launched intravascular lithotripsy (IVL), a minimally invasive system that uses ultrasonic acoustic pressure waves to break up calcified plaque in coronary arteries. For years, interventional cardiologists had been performing various types of atherectomy, a procedure in which doctors remove hardened plaque from inside an artery using specialized devices so blood can flow more easily. They were also using balloon catheters to inflate a tiny balloon inside a narrowed artery to widen it and restore blood flow.
Yet these interventions were often too risky for patients with the most severe cases of arterial calcification—patients whose arteries had hardened and narrowed so much, these devices couldn’t reliably work safely.
Enter Shockwave’s IVL technology, which adds ultrasonic acoustic pressure waves to balloon-based catheter interventions. The ultrasonic acoustic pressure waves produced by Shockwave’s IVL technology are tuned to safely make tiny cracks in hardened plaque, which in turn make the arteries more compliant. The company’s founders showed Stephens a video of a longtime interventional cardiologist using Shockwave IVL for the first time. Stephens will never forget the look he saw on that doctor’s face.
Every time we develop a new therapy or catheter, we always ask, ‘How can we treat more patients?’ and ‘How can we allow physicians to more easily treat their current patient populations?’
In that moment, Stephens was convinced Shockwave IVL could revolutionize the treatment of both calcified CAD and PAD. He joined the company as Shockwave’s Vice President of Research and Development and later took his current role of Vice President of Global Research, Technology and Development.
We spoke to Stephens about the challenges of treating CAD and PAD, plus how Shockwave is continuing to innovate with a new IVL system launching in the first half of 2026, so even more patients—especially those once considered difficult to treat—get access to necessary medical treatments.
Q:
What are the current challenges in treating CAD and PAD?
A:
A big challenge is that many patients are coming in with symptoms later, when each disease is more complex. If they’re treated earlier, chances are the arteries have softer plaque, which is easier to treat.
When patients wait longer to get care, their disease is often more difficult to treat, because there is often calcification, or hardened plaque, in the artery. That calcification makes the artery much more difficult to dilate. As a result, when you go in with a balloon angioplasty catheter and then try to dilate the artery and ultimately restore blood flow, the chance of getting an adverse event—such as a dissection in the tissue or, in the worst case, a perforation of the artery—increases significantly.
Q:
How do Shockwave’s IVL systems work?
A:
Shockwave IVL uses tuned ultrasonic acoustic pressure waves—or shock waves—to modify arterial calcification. Shock waves create small cracks when they come into contact with calcification and safely pass through healthy tissue due to the similar density between the tissue and the contrast/saline mix in the balloon. These small cracks allow improved relative movement of the artery and increase the compliance of the blood vessel. In other words, it feels more like a healthy blood vessel. But more importantly, the artery is more compliant, making it possible for a stent to hold it open with less risk of complications.
Think of your car’s windshield, which has a membrane on it to make it shatterproof glass. If a large rock hits your window and it shatters, you can see all those little cracks throughout the glass, but the glass remains intact. That’s very similar to what happens to the calcification in your arterial wall when we make cracks with IVL.
The calcification remains there. We’re not actually removing the calcification; we’re just modifying it with all these small cracks to allow it to become more compliant and stretch safely, so a balloon catheter or stent can be used to restore blood flow.
Q:
Why is it so important to target calcifications?
A:
Calcification has been one of the biggest challenges to getting effective outcomes for patients with cardiovascular disease. What we’re trying to do is give physicians a tool where they can safely create these small cracks in arterial calcium, which allows them to then treat the patients like they would patients that don’t have calcifications. In the absence of the IVL technology, calcified patients will likely get suboptimal outcomes.
Q:
How many IVL platforms does Shockwave have in its portfolio?
A:
For both CAD and PAD, we have two product platforms, one balloon-based, one catheter-based.
We started with balloon-based technologies to treat each disease. These are designed to look and feel very much like what physicians are accustomed to using, which are balloon catheters to treat arterial disease. What we did was put an emission source for a shock wave inside the balloon catheters. So essentially, you inflate a balloon, and then you deliver energy with the Shockwave IVL device to create shock waves that effectively and safely modify the calcification in the artery, making it more compliant.
As we’ve treated more and more challenging patients, it became clear that patients often had severe disease where the calcium made the artery really tight—so tight that you might not be able to fit a balloon catheter past the tightest location in the artery. We wanted a device that could treat those patients. So we created a non-balloon-based catheter therapy, which we call the Shockwave Javelin Peripheral IVL catheter.
With Shockwave Javelin, we were able to place the emission source—or emitter—of the shock wave close to the tip of the catheter. The result is you’re able to advance a catheter through very tight arteries with that device, which is something you can’t do with balloon-based IVL technology.
Q:
How does Shockwave IVL affect the work of interventionalists?
A:
When it comes to treating calcified lesions, there are other technologies that have been available longer than Shockwave IVL. The most common is rotational atherectomy, a procedure performed with a tiny burr on a catheter that’s used to grind down calcified plaque in narrowed arteries. People jokingly call it a “Roto-Rooter” for the heart.
But it’s cumbersome and can be risky to use, and because of that, there are few physicians who are specialists in it. If you don’t know how to use it well, there can be safety challenges with it.
Shockwave IVL is an incredibly safe and easy-to-use technology. That’s one of the reasons that it’s been adopted so broadly. The majority of hospitals have Shockwave IVL on their shelves.
Q:
What benefits does IVL offer patients?
A:
Shockwave IVL has favorable procedural complication rates compared to rotational atherectomy. When we talk to physicians, we hear something similar. That’s why our technologies are designed to simplify procedures and enhance safety, offering predictable and reliable results for both physicians and patients.
Q:
What does Shockwave envision as the next generation of IVL?
A:
The next IVL system, the Shockwave C2 Aero IVL catheter, is expected to come out in the first half of 2026. Shockwave C2 Aero will make it easier for interventionalists to deliver, reach and cross-target lesions with severe calcium as compared to our prior coronary device.
We’re also just finishing our Shockwave Javelin Coronary study, and I am certain we will identify ways we can improve on that design.
We’ve been working on some development projects for difficult-to-treat lesions. We have some exciting prototypes that I think are going to address difficult cases more efficiently and more effectively than we do today. Every time we develop a new therapy or catheter, we always ask, “How can we treat more patients?” and “How can we allow physicians to more easily treat their current patient populations?”
One of the things we’re talking about internally is smart devices. How can we get feedback from the catheter procedure that could ultimately optimize IVL treatment for every patient? Just like we’re getting smarter and more individualized with targeted dosages of medication, for example, the same could be true for Shockwave IVL.
Right now, we have very effective devices. We want them to ultimately be smart devices.
