Johnson & Johnson MedTech has announced new one-year data on its Shockwave Javelin Peripheral IVL Catheter, presented at the Vascular InterVentional Advances (VIVA) 2025 conference in Las Vegas. The device is designed to treat patients with peripheral artery disease (PAD) by modifying calcified or severely narrowed blood vessel lesions.
The findings from the FORWARD PAD study indicate low rates of major amputation and cardiovascular death among a high-risk patient group. According to JD Corl, M.D., Medical Director of the PAD/CLI Program at The Lindner Center for Research and Education at The Christ Hospital and Principal Investigator of the study, “These one year outcomes show that Shockwave Javelin demonstrated 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. 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 results after 12 months include a 1% rate of target limb major amputation and a 3.9% rate of cardiovascular death. Clinically driven target lesion revascularization was reported at 14.7%. Patency rates were 72.7% above-the-knee and 61.5% below-the-knee.
Nick West, M.D., Chief Medical Officer at Shockwave Medical, said: “These one-year data strengthen our conviction in Javelin as a safe, effective solution for modifying and crossing the most complex PAD lesions. 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.”
Peripheral artery disease affects over 12 million people in the United States according to research published by the American Heart Association (https://www.ahajournals.org/doi/10.1161/CIR.0000000000001153). Patients with PAD have reduced blood flow to their legs which increases their risk for heart attack or stroke (https://www.cdc.gov/heart-disease/about/peripheral-arterial-disease.html). Chronic limb-threatening ischemia is considered the most advanced form of PAD; it impacts nearly two million Americans and is associated with high rates of amputation and mortality within five years (https://www.ahajournals.org/doi/full/10.1161/CIRCOUTCOMES.120.007539), sometimes exceeding those seen in several types of cancer (https://www.hmpgloballearningnetwork.com/site/jcli/editorialcommentary/cli-major-public-health-concern-prognosis-worse-many-types-cancer).
The feasibility studies MINI S and FORWARD PAD enrolled 110 patients across multiple centers; 103 had heavily calcified arterial lesions with an average length of 77mm.
Shockwave Medical Inc., part of Johnson & Johnson MedTech, develops technologies such as Intravascular Lithotripsy (IVL) for treating cardiovascular diseases by using ultrasonic pressure waves to break up calcified plaque inside arteries.
The company noted that statements about future performance are forward-looking and subject to risks detailed in its filings with the Securities and Exchange Commission.
Dr. Corl disclosed being a paid consultant for Shockwave Medical but was not compensated specifically for this press release.