Shockwave Medical, part of Johnson & Johnson MedTech, announced the U.S. launch of its Shockwave Javelin Peripheral IVL Catheter, a novel intravascular lithotripsy (IVL) platform designed to modify calcium and cross extremely narrowed vessels in patients with peripheral artery disease (PAD). The forward IVL platform has a similar safety and efficacy profile of legacy Shockwave IVL catheters and bolsters the company’s market-leading IVL portfolio.
PAD is the narrowing or blockage of the vessels that carry blood from the heart to the legs, reducing blood flow and affecting more than eight million people aged 40 and older in the U.S. People suffering from PAD have impaired quality of life and increased risk of heart attack or stroke. Chronic limb-threatening ischemia (CLTI) is the most advanced and serious form of PAD, impacting nearly two million patients in the U.S. It is associated with 40% major amputations at one year and a 50% mortality rate at five years, worse than most forms of cancer.
The forward IVL platform is designed to modify calcium and cross calcified occlusive disease or extremely narrowed lesions where a wire will cross but devices might not. Shockwave Javelin has a working length of 150 centimeters and features a single distal emitter that creates up to 120 shockwave pulses. Each shockwave pulse creates a spherical energy field that extends beyond the tip of the catheter. This novel design delivers lithotripsy closer to calcium than the balloon-based platform. Despite the challenging nature of the calcified lesions studied, the clinical outcomes from the FORWARD PAD IDE trial demonstrated that Shockwave Javelin has a similar safety and effectiveness profile to balloon-based Shockwave IVL catheters.
Combined with Shockwave E8, Shockwave L6, Shockwave M5+, and Shockwave S4 IVL catheters, the addition of the Shockwave Javelin Peripheral IVL catheter offers physicians a comprehensive IVL portfolio to treat challenging calcified lesions above and below the knee across the entire peripheral anatomy.
