Johnson & Johnson MedTech Data Backs Shockwave Javelin Peripheral IVL Catheter

Johnson & Johnson MedTech has revealed one-year results in patients treated with its Shockwave Javelin peripheral IVL (intravascular lithotripsy) catheter.

Javelin is a Forward IVL platform that modifies calcified occlusive or extremely narrowed lesions in patients with peripheral artery disease (PAD). The results presented as a late-breaking clinical trial at this year’s Vascular InterVentional Advances (VIVA) meeting showed low rates of major amputation and cardiovascular death in a high-risk, complex patient population.

The 12-month rate of target limb major amputation was 1% at one year, with a cardiovascular death rate of 3.9%. CD-TLR rate was 14.7% and primary patency above-the-knee was 72.7%, with below-the-knee patency at 61.5%.

JD Corl, M.D., F.A.C.C., F.S.C.A.I., 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 said the one year outcomes show that Shockwave Javelin showed lasting durability, with most patients remaining free from repeat intervention.

“Severe calcification has long been one of the greatest challenges in endovascular treatment of PAD, driving higher rates of complications, mortality and limb loss, Dr. Corl told the press. “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.”

The feasibility and IDE studies of the Javelin IVL catheter (MINI S and FORWARD PAD, respectively) were prospective, multi-center, single-arm, angiographic core-lab adjudicated studies with similar inclusion and exclusion criteria. The studies enrolled 110 patients, with 103 with heavily calcified, stenotic peripheral arterial lesions.

The average lesion length was 77mm, just under half of the target lesions were located below the knee, and over a third were chronic total occlusions.

“These one-year data strengthen our conviction in Javelin as a safe, effective solution for modifying and crossing the most complex PAD lesions,” said Nick West, M.D., chief medical officer at Shockwave Medical. “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.”