DISRUPT BTK II Confirms Durability and Safety of IVL for Complex BTK Disease

November 3, 2025—Johnson & Johnson MedTech announced 1-year results from the DISRUPT BTK II postmarket study, demonstrating sustained safety and effectiveness of the Shockwave peripheral intravascular lithotripsy (IVL) system for treating calcified below-the-knee (BTK) lesions in patients with peripheral artery disease (PAD). The findings, presented as late-breaking data at the 2025 Vascular InterVentional Advances (VIVA) meeting, reinforce IVL’s durability and clinical benefits in complex BTK anatomy, particularly among patients with chronic limb-threatening ischemia (CLTI).

According to the company’s release, DISRUPT BTK II included 250 patients across 38 global sites, with 80% of patients presenting with CLTI. The trial was designed as a prospective, multicenter, single-arm, core lab–adjudicated evaluation of real-world outcomes, enrolling 305 lesions in total.

At 1 year, freedom from major target limb amputation was achieved in 94.8% of patients, with no amputations reported in non-CLTI patients. Freedom from clinically driven target lesion revascularization (CD-TLR) was 84.5%, and durable patency was observed in 67.1% of patients. Rutherford class improvement of at least one category was achieved in 75.5% of patients, nearly half of whom became asymptomatic. Additionally, 61.3% showed wound healing or improvement.

Among the CLTI subgroup, 8.1% of patients underwent amputation at 1 year. The proportion of patients with CLTI-level Rutherford classification decreased from 80.1% at baseline to 25.1%, while the Vascular Quality of Life (VascuQoL) score improved significantly (mean increase of > 5 points; 11.9 ± 4 to 17.2 ± 5, P < .001). Primary patency among CLTI patients was 64%, and 82.7% remained free from CD-TLR at 1 year.

“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,” commented Ehrin Armstrong, MD, interventional cardiologist and Medical Director at Adventist Heart & Vascular Institute, who presented the data.

Venita Chandra, MD, vascular surgeon and clinical professor at Stanford Health Care, added, “These data underscore IVL’s critical role in wound healing and helping limb preservation. We will continue tracking patient outcomes through 2 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.” 

Johnson & Johnson MedTech stated that the Shockwave peripheral IVL system continues to show promise as a treatment option for patients with severe PAD and complex BTK anatomy, offering durable results and low amputation rates in a population with limited revascularization alternatives.