Johnson & Johnson MedTech presented new one-year results from the DISRUPT BTK II study at the Vascular InterVentional Advances (VIVA) 2025 meeting in Las Vegas. The post-market trial evaluated the safety and effectiveness of the Shockwave Peripheral Intravascular Lithotripsy (IVL) System for treating calcified lesions below the knee in patients with peripheral artery disease (PAD), including a large group with chronic limb-threatening ischemia (CLTI).
“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, Adventist Heart & Vascular Institute, 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.”
At one year, 94.8% of patients were free from major target limb amputation, with no amputations among non-CLTI patients. Clinically driven target revascularization was avoided in 84.5% of patients, while durable patency was observed in 67.1%. Additionally, 75.5% saw improvement in Rutherford Class status; nearly half became asymptomatic after one year, and wound healing or improvement occurred in 61.3%.
Among CLTI patients—who made up 80% of those studied—8.1% had an amputation at one year. The percentage classified as CLTI by Rutherford criteria dropped from 80.1% at baseline to 25.1%. There was significant symptomatic improvement as measured by VascuQoL scores, increasing by more than five points over baseline values (from 11.9 ± 4.0 to 17.2 ± 5.0). For these patients, freedom from clinically driven target lesion revascularization was seen in 82.7%, and primary patency rate reached 64%.
“These data underscore IVL’s critical role in wound healing and helping limb preservation,” said Venita Chandra, M.D., Vascular Surgeon and Clinical Professor at Stanford Health Care’s Division of Vascular Surgery. “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.”
The DISRUPT BTK II study enrolled 250 patients across 38 global sites, including those with complicated conditions: most had CLTI (80%), diabetes mellitus (70%), moderate-to-severe calcium deposits (85%), wounds at baseline (58.5%), or chronic total occlusions (30%). This makes it a pioneering effort reflecting real-world challenges faced by people living with advanced PAD.
Peripheral artery disease affects over twelve million people in the United States alone according to research published by the American Heart Association (source). It can reduce quality of life and increase risk for heart attack or stroke (source). Chronic limb-threatening ischemia is considered its most serious form; it impacts about two million Americans (source) and is associated with high rates of major amputations within a year as well as increased mortality compared to many cancers (source).
Shockwave Medical Inc., part of Johnson & Johnson MedTech, develops intravascular lithotripsy technology that uses ultrasonic pressure waves to break up calcified plaque inside blood vessels.
Forward-looking statements related to future expectations for Shockwave Javelin Peripheral IVL Catheter are included in this announcement; actual results may differ due to various risks described in Johnson & Johnson’s filings with the Securities and Exchange Commission.
Drs. Chandra and Armstrong are paid consultants for Shockwave Medical but were not compensated specifically for their involvement in this press release.