J&J’s Shockwave Peripheral IVL Evaluated at 24 Months in DISRUPT BTK II Postmarket Study

October 8, 2026—Johnson & Johnson MedTech announced 24-month results from the DISRUPT PAD BTK II postmarket study assessing the continued safety and effectiveness of the company’s Shockwave peripheral intravascular lithotripsy (IVL) system for treating calcified below-the-knee (BTK) lesions in patients with peripheral artery disease (PAD).

The company noted that the DISRUPT PAD BTK II study included highly challenging patients including a high proportion with chronic limb-threatening ischemia (CLTI) typically excluded from studies.

Venita Chandra, MD, presented the findings in a late-breaking trials session at VIVA 2026, the Vascular Interventional Advances conference.

According to the company, the data demonstrated sustained clinical benefits in complex patients with calcified BTK disease, including Rutherford class improvement, significant quality-of-life gains, low reintervention rates, and ongoing limb preservation through 2 years.

As summarized by the company, key findings from the full cohort at 24 months include the following:

• Freedom from major target limb amputation was achieved in 94.8% of patients, with no amputations in non-CLTI patients.
• Freedom from clinically driven target lesion revascularization was achieved in 81% of patients.
• Significant symptomatic and VascuQoL improvements were documented, with a more than 6-point improvement from baseline (12.1 ± 4.0 to 18.3 ± 4.5; P < .001).

Additional information on the clinical evidence from the 24-month analysis is available on the company’s website.

The company provided commentary on the findings from Dr. Chandra, vascular surgeon and Clinical Professor, Division of Vascular Surgery at Stanford Health Care in Stanford, California.

“These 24-month results are especially meaningful because they demonstrate durable clinical benefit in a highly complex, real-world population with CLTI—patients for whom achieving sustained outcomes can be particularly difficult,” stated Dr. Chandra. “The improvements in symptoms and quality of life, together with high rates of freedom from major amputation and reintervention, reinforce Shockwave IVL as an important frontline calcium-modification strategy for treating complex BTK disease.”

The 1-year results from the DISRUPT PAD BTK II study were presented by Dr. Chandra at VIVA 2025.