In late-breaking data presented at the Vascular InterVentional Advances 2026 conference in Las Vegas, the company showed that benefits were maintained in complex patients out to two years, alongside a continuing decline in the number facing chronic limb-threatening ischemia, the final and most severe stage of the disease.
Compared to about 80% of the 250 participants at the study’s baseline, that CLTI figure dropped to 50% after 30 days, before reaching 25% at 12 months and 14% after 24 months.
Previous findings from the study, known as DISRUPT BTK II, were also spotlighted at the VIVA conference last year, including the one-year measure showing 94.8% of patients did not require a major limb amputation.
That rate held steady into two years for the study’s full cohort, and reached 93.3% among patients with CLTI. Additionally, 81% of patients avoided repeated revascularization procedures.
“These 24-month results are especially meaningful because they demonstrate durable clinical benefit in a highly complex, real-world population with chronic limb-threatening ischemia—patients for whom achieving sustained outcomes can be particularly difficult,” said the study’s presenter, Dr. Venita Chandra, clinical professor of vascular surgery at Stanford Health Care.
“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 below-the-knee disease,” Chandra added in a statement.
In the past two years, J&J has developed new Shockwave catheters aimed at challenging lesions, following its $13.1 billion acquisition in 2024.
That includes those for calcifications below the knee, such as the Javelin system designed to deliver energy forward from its tip instead of around its circumference through a balloon. The company also launched its next-gen C2 Aero coronary catheter earlier this year.
At the start of this month, the Shockwave Medical name was retired and the unit folded into the broader J&J MedTech circulatory restoration solutions business, though the moniker remains on its devices.
