Johnson & Johnson MedTech has announced strong one-year outcomes from its DISRUPT BTK II study, which confirmed the durability, safety, and effectiveness of the Shockwave Peripheral Intravascular Lithotripsy (IVL) System for treating severely calcified lesions below the knee (BTK) in patients with peripheral artery disease (PAD).

The post-market study, which included a high proportion of patients (80%) suffering from chronic limb-threatening ischemia (CLTI), demonstrated meaningful clinical improvements and low amputation rates.

The study demonstrated strong clinical outcomes, with 94.8 per cent of subjects remaining free from major target limb amputation at one year, and no amputations reported among participants without CLTI at baseline. Additionally, 84.5 per cent of patients avoided clinically driven target revascularisation within the same period, while durable vessel patency was observed in 67.1 per cent of subjects. Clinical improvement by at least one Rutherford Class was seen in 75.5 per cent of participants, with nearly half becoming asymptomatic at the one-year mark. Furthermore, wound healing or improvement was achieved in 61.3 per cent of patients.

Among participants with CLTI—representing 80 per cent of the study population—8.1 per cent experienced an amputation within one year. Notably, the proportion of patients classified as having CLTI based on Rutherford criteria improved significantly, from 80.1 per cent at baseline to 25.1 per cent at one-year follow-up. In this subgroup, 82.7 per cent remained free from clinically driven target lesion revascularisation, while primary patency was maintained in 64 per cent after one year.

Led by Stanford Health Care’s Division of Vascular Surgery clinical professor and vascular surgeon Dr. Venita Chandra, and Adventist Heart & Vascular Institute’s medical director and interventional cardiologist Dr. Ehrin Armstrong, the trial enrolled 250 patients across 38 global sites, addressing 305 lesions in total. The study cohort included 200 patients with CLTI; 58.5 per cent presented with wounds, 70 per cent had diabetes mellitus, 30 per cent had chronic total occlusions, and 85 per cent had moderate-to-severe arterial calcification.

Dr. Chandra stated, “We will continue tracking patient outcomes through two years to evaluate the long-term durability of these compelling results, and we look forward to further analyses to optimise outcomes in this complex, real-world patient population.”

The promising one-year data reinforces the potential of J&J MedTech’s Shockwave Peripheral IVL System to deliver durable, clinically meaningful benefits for patients with complex peripheral artery disease. In September 2025, the company expanded its vascular innovation portfolio with the European launch of the Shockwave Javelin Peripheral IVL Catheter, designed to address calcium deposits in severely narrowed blood vessels.