Johnson & Johnson One-Year Data Demonstrate Durable Performance and Safety of the Shockwave Javelin Peripheral IVL Catheter in Late-Breaking Presentation at VIVA 2025
Findings demonstrate durable benefits and low complication rates, enabling treatment for severely calcified, difficult-to-cross peripheral lesions
Findings demonstrate durable benefits and low complication rates, enabling treatment for severely calcified, difficult-to-cross peripheral lesions
Johnson & Johnson MedTech News
LAS VEGAS – Johnson & Johnson MedTech, a global leader in the field of circulatory restoration, today announced the one-year results in patients treated with its Shockwave Javelin Peripheral IVL Catheter, a novel Forward IVL platform designed to modify calcified occlusive or extremely narrowed lesions in patients with peripheral artery disease (PAD). The results, presented as a late-breaking clinical trial at the annual Vascular InterVentional Advances (VIVA) meeting, demonstrate 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 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.i “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 findings from the one-year data analysis include:
- Low Rates of Major Amputation: The 12-month rate of target limb major amputation was 1.0%.
- Low Rates of Cardiovascular Death: At one year, the cardiovascular death rate was 3.9%.
- CD-TLR Rate of 14.7%.
- Durable Patency: At one-year, primary patency above-the-knee (ATK) was 72.7% and below-the-knee (BTK) 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 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.”
Peripheral artery disease is the narrowing or blockage of the vessels that carry blood from the heart to the legs, reducing blood flow and affecting more than 12 million people in the U.S. alone.1 People suffering from PAD have an impaired quality of life and increased risk of heart attack or stroke.2 Chronic limb-threatening ischemia is the most advanced and serious form of PAD, impacting nearly 2 million patients in the U.S. It is associated with 40% major amputations at one year and a 50% mortality rate at five years,3 worse than many forms of cancer.4
The feasibility and IDE studies of the Shockwave 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.
About Shockwave Medical
Shockwave Medical, Inc., part of Johnson & Johnson MedTech, is a leader in the development and commercialization of innovative products that are transforming the treatment of cardiovascular disease. Its first-of-its-kind Intravascular Lithotripsy (IVL) technology has transformed the treatment of atherosclerotic cardiovascular disease by safely using ultrasonic pressure waves to disrupt challenging calcified plaque, resulting in significantly improved patient outcomes. Its Reducer technology, which is under clinical investigation in the United States and is CE Marked in the European Union and the United Kingdom, is designed to provide relief to the millions of patients worldwide suffering from refractory angina by redistributing blood flow within the heart. Learn more at www.shockwavemedical.com.
Cardiovascular Solutions from Johnson & Johnson MedTech
Across Johnson & Johnson, we are tackling the world’s most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation, we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector’s global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at https://thenext.jnjmedtech.com. Follow us at @JNJMedTech and on LinkedIn.
iDr. Corl is a paid consultant for Shockwave Medical. He has not been compensated in connection with this press release.
- https://www.ahajournals.org
- https://www.cdc.gov
- https://www.ahajournals.org
- https://www.hmpgloballearningnetwork.com
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