Johnson & Johnson's Shockwave IVL System Demonstrates Strong One-Year Outcomes in Complex Peripheral Artery Disease Treatment
核心洞察
Johnson & Johnson MedTech (搜索) reported promising one-year results from the DISRUPT BTK II study, showing 94.8% of patients avoided major amputation and 84.5% remained free from revascularization.
The study validated the Shockwave Peripheral Intravascular Lithotripsy System (搜索)'s effectiveness in treating severely calcified below-the-knee lesions in 250 patients with peripheral artery disease (搜索).
Among the 80% of patients with chronic limb-threatening ischemia (搜索), only 8.1% experienced amputation within one year, with significant clinical improvements observed.
Johnson & Johnson MedTech (搜索) has unveiled compelling one-year data from the DISRUPT BTK II study at the Vascular InterVentional Advances (VIVA) 2025 conference in Las Vegas, demonstrating the sustained effectiveness of the Shockwave Peripheral Intravascular Lithotripsy (IVL) System in treating complex below-the-knee calcified lesions in patients with peripheral artery disease (搜索) (PAD).
The post-market study enrolled 250 patients across 38 global sites, addressing 305 lesions in total, with a particularly challenging patient population where 80% suffered from chronic limb-threatening ischemia (搜索) (CLTI). The study cohort included patients with significant comorbidities: 58.5% presented with wounds, 70% had diabetes mellitus (搜索), 30% had chronic total occlusions, and 85% had moderate-to-severe arterial calcification.
Strong Clinical Outcomes at One Year
The study demonstrated impressive clinical results, with 94.8% of subjects remaining free from major target limb amputation at one year. Notably, no amputations were reported among participants without CLTI at baseline. Additionally, 84.5% of patients avoided clinically driven target revascularization within the same period, while durable vessel patency was observed in 67.1% of subjects.
Clinical improvement by at least one Rutherford Class was seen in 75.5% of participants, with nearly half becoming asymptomatic at the one-year mark. Furthermore, wound healing or improvement was achieved in 61.3% of patients, highlighting the system's potential to address critical clinical needs in this high-risk population.
CLTI Patient Outcomes
Among participants with CLTI—representing 80% of the study population—8.1% experienced an amputation within one year. The proportion of patients classified as having CLTI based on Rutherford criteria improved significantly, from 80.1% at baseline to 25.1% at one-year follow-up. In this subgroup, 82.7% remained free from clinically driven target lesion revascularization, while primary patency was maintained in 64% after one year.
Clinical Leadership and Future Directions
The trial was led by Dr. Venita Chandra, clinical professor and vascular surgeon at Stanford Health Care's Division of Vascular Surgery, and Dr. Ehrin Armstrong, medical director and interventional cardiologist at Adventist Heart & Vascular Institute (搜索).
"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 optimize outcomes in this complex, real-world patient population," stated Dr. Chandra.
Expanding Treatment Options
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 (搜索). In September 2025, the company expanded its vascular innovation portfolio with the European launch of the Shockwave Javelin Peripheral IVL Catheter (搜索), designed to address calcium deposits in severely narrowed blood vessels.
These outcomes underscore IVL's potential as a first-line strategy against calcification, particularly in a high-risk patient demographic where traditional treatment options may be limited.