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.
PAD is the narrowing or blockage of the vessels that carry blood to the legs that reduce blood flow, resulting in debilitating symptoms, ulceration and an increased risk of amputation. People suffering from PAD have an impaired quality of life and increased risk of heart attack or stroke. More than 230 million people worldwide and around 15 million people aged 45 and older in Europe suffer from PAD. Chronic limb-threatening ischemia (CLTI), the most advanced and serious form of PAD impacting nearly 25 million patients worldwide,
has a 40% major amputation rate at one year from initial diagnosis and a 50% mortality rate at five years, worse than most forms of cancer.
“The Shockwave Javelin Peripheral IVL catheter helps address one of the most persistent technical barriers in complex below the knee (BTK) revascularization – the ‘device-uncrossable’ calcified lesion,” said Dr. Narayanan Thulasidasan, Consultant Interventional Radiologist at Guy’s and St Thomas’ NHS Foundation Trust, London, UK.
†“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.
“Shockwave is at the forefront of IVL technology, and we continue to address unmet physician needs,” said Nick West, M.D., Chief Medical Officer, Shockwave Medical. “We developed our first-of-its-kind forward IVL platform through conversations with physicians, leveraging their valuable insights to develop a platform with the capability to modify calcium and cross extremely narrowed vessels. We are proud to set the standard in generating an expansive portfolio for endovascular interventionalists to address their unmet needs and move the goalposts of what’s expected from IVL technology in the reduction of risks associated with CLTI.”
Intravascular Lithotripsy (IVL) is the energy-based generation of ultrasonic acoustic pressure waves for modification, fracture and fragmentation of vascular calcification. Combined with Shockwave E8, Shockwave L6 & Shockwave M5+ IVL catheters, the addition of the Shockwave Javelin Peripheral IVL catheter offers physicians a comprehensive IVL portfolio to treat challenging calcified lesions both above and below the knee, spanning the entire peripheral anatomy.
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