Santa Clara:Johnson & Johnson has announced the European launch of its Shockwave Javelin Peripheral IVL Catheter, a novel intravascular lithotripsy (IVL) platform designed to modify calcium in extremely narrowed vessels to expand treatments in patients suffering from peripheral artery disease (PAD). The Forward IVL platform includes a catheter with a single lithotripsy emitter placed directly behind the tip of the device and has a similar safety and effectiveness profile to legacy Shockwave IVL catheters, bolstering the company’s IVL portfolio. “Previously, there were few reliable options for effective treatment of these uncrossable BTK vessels. The Javelin IVL catheter helps bridge a critical gap in the management of CLTI in patients with complex multi-level disease,” said Dr. Ashish Patel, Consultant Vascular and Endovascular Surgeon at Guy’s and St Thomas’ NHS Foundation Trust and Reader in Vascular Surgery and Sciences at King’s College London in London, UK.† As per the company, the novel Javelin Forward IVL platform is designed to modify 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 can provide 120 shock waves, spherical ultrasonic acoustic pressure waves, that extend beyond the tip of the catheter. This novel design allows delivery of lithotripsy closer to occlusive calcific lesions than the balloon-based platform could enable. Despite the challenging nature of the complex patients and 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.