Shockwave Medical’s IVL catheter for peripheral lesions linked to positive 1-year data
Shockwave Medical, a Johnson & Johnson MedTech company, has announced new one-year data on its intravascular lithotripsy (IVL) device designed to target calcium in patients with peripheral artery disease (PAD) and chronic limb-threatening ischemia (CLTI).
The findings, presented at the annual VIVA meeting in Las Vegas, focused on data from 110 patients with an average lesion length of 77 mm. More than one-third of the lesions were chronic total occlusions.
Overall, Shockwave Medical’s Javelin Peripheral IVL Catheter was linked to a 1% rate of target limb major amputation and 3.9% rate of cardiovascular death after one year. The clinically driven target lesion revascularization rate after one year was 14.7%. Rates of one-year primary patency, meanwhile, were 72.7% for above-the-knee lesions and 61.5% for below-the-knee lesions.
“These one-year data strengthen our conviction in Javelin as a safe, effective solution for modifying and crossing the most complex PAD lesions,” Nick West, MD, chief medical officer at Shockwave Medical, said in a statement. “The durable benefits we’re seeing—specifically in difficult-to-cross, severely calcified disease—signal a step change in how clinicians can approach these cases. We remain committed to advancing innovations that expand options and elevate outcomes for PAD patients.”
“Severe calcification has long been one of the greatest challenges in endovascular treatment of PAD, driving higher rates of complications, mortality and limb loss,” added principal investigator JD Corl, MD, an interventional cardiologist medical director of the PAD/CLI Program at The Lindor Center for Research and Education at The Christ Hospital. “Until now, clinicians lacked a technology that could modify calcium safely to enable the crossing of heavily stenosed lesions. These results demonstrate that IVL is not just overcoming that barrier—it is redefining what’s possible and enabling optimized outcomes for a broader population of PAD patients.”
Key details about the Javelin Peripheral IVL Catheter
The Javelin Peripheral IVL Catheter is 150 cm long and features a single distal emitter capable of creating up to 120 shockwave pulses. In addition, its balloon-free design helps deliver those pulses closer to calcified lesions than balloon-based IVL catheters.
Shockwave Medical launched the Javelin Peripheral IVL Catheter in the United States in March 2025, pointing to positive data first presented at the 2024 VIVA meeting.
Click here to watch a full video interview Corl did with Cardiovascular Business about the Javelin Peripheral IVL Catheter.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.