Johnson & Johnson Confirms Durability of IVL in Complex, Below-the-Knee Anatomy 

Johnson & Johnson MedTech today announced one-year results of DISRUPT BTK II, a post-market study to assess the Shockwave Peripheral IVL System’s continued safety and effectiveness in treating calcified below the knee (BTK) lesions in patients 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 at Adventist Heart & Vascular Institute,ⁱ 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 five-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.ⁱ “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 Drs. Chandra and Armstrong. The study enrolled 250 patients with 305 lesions at 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, according to the company. 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 vessels carrying blood from the heart to the legs, reducing blood flow and affecting more than 12 million people in the United States.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 U.S. patients. 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 

Shockwave Medical Inc., part of Johnson & Johnson MedTech, develops and commercializes products that treat 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 patients suffering from refractory angina by redistributing blood flow within the heart.

Johnson & Johnson tackles 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, the healthcare behemoth addresses conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. The company considers itself a global leader in heart recovery, circulatory restoration, and heart rhythm disorder treatment, as well as an emerging leader in neurovascular care. 

Through its expertise in Innovative Medicine and MedTech, Johnson & Johnson is positioned to innovate across the full spectrum of healthcare solutions to deliver breakthroughs and profoundly impact health.

ⁱ Drs. Chandra and Armstrong are paid consultants for Shockwave Medical.
* 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. 

References
¹ https://www.ahajournals.org
² https://www.ahajournals.org
³ https://www.cdc.gov
⁴ https://www.hmpgloballearningnetwork.com