Johnson & Johnson MedTech‘s Shockwave Medical today announced one-year results in a study using its Javelin peripheral IVL catheter.
Yesterday, the company shared findings from a separate intravascular lithotripsy (IVL) study. It presented findings at the annual Vascular InterVentional Advances (VIVA) meeting in Las Vegas. Today, it shared further IVL findings, this time for its novel, first-of-its-kind forward IVL platform.
The Javelin non-balloon catheter comprises part of the company’s forward IVL platform that features a similar safety and effectiveness profile to legacy Shockwave IVL catheters. The system aims to modify calcium and cross significantly narrowed vessels in patients with peripheral artery disease (PAD).
Shockwave launched Javelin in the U.S. in March, then launched in Europe in September. Chief Medical Officer Dr. Nick West recently spoke to Medical Design & Outsourcing about the latest developments at the company.
New findings shared at VIVA demonstrated low rates of major amputation and cardiovascular death in a high-risk, complex patient population.
“These one year outcomes show that Shockwave Javelin demonstrated lasting durability, with most patients remaining free from repeat intervention,” said Dr. JD Corl, medical director of the PAD/CLI Program at The Lindner Center for Research and Education at The Christ Hospital and Principal Investigator of the FORWARD PAD study. “Severe calcification has long been one of the greatest challenges in endovascular treatment of PAD, driving higher rates of complications, mortality and limb loss. 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.”
A look at the findings shared by Shockwave
Shockwave shared findings from the feasibility and FDA investigational device exemption (IDE) studies of Javelin. The studies were the MINI S and FORWARD PAD studies, respectively. The prospective, multi-center, single-arm, angiographic core-lab adjudicated studies had similar inclusion and exclusion criteria.
According to Shockwave, the studies enrolled 110 patients, with 103 presenting heavily calcified, stenotic peripheral arterial lesions. Average lesion length came in at 77mm. Just under half the target lesions were located below the knee (BTK). Over a third were chronic total occlusions (CTO).
Key findings include low rates of major amputation, with the 12-month target rate coming in at 1%. Investigators also saw low rates of cardiovascular death, coming in at 3.9% at one year. CD-TLR rate totaled 14.7%, while the study also reported durable patency. At one year, primary patency above the knee (ATK) was 72.7% and BTK was 61.5%.
“These one-year data strengthen our conviction in Javelin as a safe, effective solution for modifying and crossing the most complex PAD lesions,” said West. “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.”
