Johnson & Johnson Confirms Durability of IVL in Complex, Below-the-Knee Anatomy in Late-Breaking Presentation at VIVA 2025

DISRUPT BTK II one-year outcomes data demonstrate the strong safety profile and consistent effectiveness of the Shockwave Peripheral IVL system to help support wound healing and limb preservation

LAS VEGAS, November 3, 2025 – Johnson & Johnson MedTech, a global leader in the field of circulatory restoration, today announced the one-year results of DISRUPT BTK II, a post-market study to assess the continued safety and effectiveness of the Shockwave Peripheral IVL System for the treatment of calcified lesions below the knee (BTK) in patients suffering with peripheral artery disease (PAD). The trial included some of the most challenging patients studied to date, including a high proportion of patients with chronic limb-threatening ischemia (CLTI). The favorable results, presented in a late-breaking presentation at the annual Vascular InterVentional Advances (VIVA) meeting, confirm the durability of IVL in complex BTK anatomy, leading to symptom relief, limb salvage, and improved quality of life.

“Treating patients with complex BTK lesions has always been a major challenge with limited options available. DISRUPT BTK II sets a new standard by introducing IVL as a frontline strategy to modify calcification and restore vessel compliance for this high-risk patient population,” said Ehrin Armstrong, M.D., Interventional Cardiologist and Medical Director, Adventist Heart & Vascular Institute,† who presented the data. “Shockwave IVL is one of the first technologies rigorously tested in severely calcified lesions, delivering low amputation rates and meaningful symptom relief—a major milestone in vascular care.”

Key findings from the full cohort at one year include:

  • Freedom from Major Target Limb Amputation was achieved in 94.8% of patients at one year, with no amputations in non-CLTI patients.
  • Freedom from Clinically Driven Target Revascularization was achieved in 84.5% of patients at one year.
  • Durable Patency* was observed in 67.1% of patients at one year.
  • RC Class Improvement was achieved in 75.5% of patients at one year. Patients improved from their baseline Rutherford Class status by at least one class with nearly 50% rendered asymptomatic at one year. Additionally, wound healing or improvement was observed in 61.3% of patients.

Key findings within the CLTI cohort at one year, which comprised 80% of trial patients, include:

  • In patients with CLTI at baseline, 8.1% had an amputation.
  • The proportion of patients with a CLTI Rutherford classification improved from 80.1% at baseline to just 25.1% with available one-year follow-up.
  • Significant symptomatic and VascuQoL improvements were documented with a more than 5-point improvement from baseline (11.9 ± 4.0 to 17.2 ± 5.0, p<0.001) at one year.
  • For patients with CLTI, 82.7% remained free from CD-TLR at one year.
  • At one year, primary patency rate was 64.0%.

“These data underscore IVL’s critical role in wound healing and helping limb preservation,” said Venita Chandra, M.D., Vascular Surgeon and Clinical Professor, Division of Vascular Surgery, Stanford Health Care.† “By reducing amputations and helping patients preserve mobility and independence, Shockwave IVL is transforming outcomes for patients with severe peripheral artery disease. We will continue tracking patient outcomes through two years to evaluate the long-term durability of these compelling results, and we look forward to the additional analyses to continue to optimize outcomes in this complex, real-world patient population.”

DISRUPT BTK II is a post-market, prospective, multicenter, core lab-adjudicated, single-arm study led by Venita Chandra, M.D., Vascular Surgeon and Clinical Professor, Division of Vascular Surgery, Stanford Health Care, and Ehrin Armstrong, M.D., Interventional Cardiologist and Medical Director, Adventist Heart & Vascular Institute. The study enrolled 250 patients with 305 lesions across 38 sites globally and features a complex patient cohort (200 patients with CLTI) that reflects the diverse and complicated nature of real-world CLTI cases and challenging lesions below-the-knee,1 making it a pioneering study in the BTK space. In the study, 58.5% of patients presented with baseline wounds, 80% with CLTI, 70% with diabetes mellitus, 30% with chronic total occlusions (CTOs), and 85% with moderate-to-severe calcium.

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.2 People suffering from PAD have an impaired quality of life and increased risk of heart attack or stroke.3 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,1 worse than many forms of cancer.4

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 sonic 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. Shockwave Medical, Inc. is a Johnson & Johnson company.

Cautions Concerning Forward-Looking Statements 
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to Shockwave Javelin Peripheral IVL Catheter. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

Media Contacts
Charlene DeBar
cdebar1@its.jnj.com

Erin Farley
efarley1@its.jnj.com

†Drs. Chandra and Armstrong are paid consultants for Shockwave Medical. They have not been compensated in connection with this press release.

*Primary Patency is defined as the absence of both total occlusion in all of the target lesion flow pathways, as well as any CEC adjudicated CD-TLR.

1: https://www.ahajournals.org/doi/full/10.1161/CIRCOUTCOMES.120.007539
2: https://www.ahajournals.org/doi/10.1161/CIR.0000000000001153
3: https://www.cdc.gov/heart-disease/about/peripheral-arterial-disease.html
4: https://www.hmpgloballearningnetwork.com/site/jcli/editorialcommentary/cli-major-public-health-concern-prognosis-worse-many-types-cancer