Shockwave Medical Shows Promising Results for Treating Peripheral Artery Disease in Challenging Cases
SHERIDAN, WYOMING – November 9, 2024 – Shockwave Medical, a Johnson & Johnson MedTech company, has announced encouraging results from its DISRUPT BTK II study, which investigated the use of Intravascular Lithotripsy (IVL) in patients with calcified peripheral lesions below the knee. The study focused on patients with Critical Limb-Threatening Ischemia (CLTI), a severe form of peripheral artery disease (PAD) that can lead to amputation.
PAD affects over 8 million people over 40 in the United States, with CLTI representing the most serious form. It can lead to a 40% major amputation rate within a year and a 50% mortality rate within five years.
The DISRUPT BTK II study enrolled 250 patients with 305 lesions across 38 sites worldwide. The study population included a high percentage of patients with comorbidities such as diabetes, chronic total occlusions (CTOs), and moderate-to-severe calcium, making them particularly challenging to treat.