Johnson & Johnson MedTech, a global leader in circulatory restoration, has announced strong one-year outcomes from its DISRUPT BTK II study, reaffirming the safety, effectiveness and durability of the Shockwave Peripheral Intravascular Lithotripsy (IVL) System for the treatment of calcified below-the-knee (BTK) lesions in patients with peripheral artery disease (PAD). 

The post-market study, presented as a late-breaking presentation at the annual Vascular InterVentional Advances (VIVA) meeting, evaluated one of the most challenging patient populations to date—including a high proportion suffering from chronic limb-threatening ischemia (CLTI).

The study confirmed the durability of IVL in complex BTK anatomy, leading to symptom relief, limb salvage, and improved quality of life.

“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, 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,” he added.