Today, Shockwave Medical announced the US launch of its Shockwave Javelin peripheral intravascular lithotripsy (IVL) catheter, a platform designed to modify calcium and cross narrowed vessels in patients with peripheral artery disease (PAD).
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 years and older in the United States. 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 US It is associated with 40% major amputations at one year and a 50% mortality rate at five years, worse than most forms of cancer.
“Physicians have faced significant challenges in tackling complex calcific lesions in narrowed peripheral vessels, and there is a growing need for more effective crossing and treatment tools,” said JD Corl, medical director of the PAD/CLTI programme at The Lindner Center for Research and Education at The Christ Hospital in Cincinnati, USA. “With proven safety and effectiveness similar to existing IVL devices, Shockwave’s new IVL platform will bring a transformative approach to our peripheral practices, enabling us to make cases more efficient and optimise outcomes for our patients living with PAD, especially those with more complex CLTI.”
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 150cm 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 investigational device exemption (IDE) trial demonstrated that Shockwave Javelin has a similar safety and effectiveness profile to balloon-based Shockwave IVL catheters, a company press release states.
“As the pioneer of IVL technology, our goal is to continue to deliver innovations that address the unmet needs of the physicians that we serve,” said Nick West, chief medical officer, Shockwave Medical. “By listening to and leveraging their valuable insights, we developed our transformational forward IVL platform with the unique capability to both modify calcium and cross extremely narrowed vessels. We are proud to be leading the charge in offering endovascular interventionalists more flexibility to address critical treatment needs and potentially reduce the risks associated with CLTI for their patients.”
