Shockwave Medical Introduces Forward Intravascular Lithotripsy Platform in U.S.

Shockwave Medical Inc., part of Johnson & Johnson MedTech, has commenced the U.S. launch of the Shockwave Javelin Peripheral IVL Catheter, an intravascular lithotripsy (IVL) platform designed to modify calcium and cross extremely narrowed vessels in peripheral artery disease (PAD) patients. Deemed the first of its kind, the forward IVL platform has a similar safety and efficacy profile of legacy Shockwave IVL catheters. 

PAD is the narrowing or blockage in vessels that carry blood from the heart to the legs, reducing blood flow and affecting more than 8 million people aged 40 and older in the United States.^1,2 PAD patients typically have an impaired quality of life and increased risk of a heart attack or stroke.¹ Chronic limb-threatening ischemia (CLTI) is the most advanced and serious form of PAD, impacting nearly 2 million U.S. patients. It is associated with 40% major amputations at one year and a 50% mortality rate at five years, worse than most forms of cancer.³  

“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 J.D. Corl, M.D., medical director of the PAD/CLI Program at The Lindner Center for Research and Education at The Christ Hospital.† “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 optimize 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 150-centimeter working length and features a single distal emitter that creates up to 120 shockwave pulses, according to the company. Each shockwave pulse creates a spherical energy field that extends beyond the catheter tip. This design delivers lithotripsy closer to calcium than the balloon-based platform. Despite the challenging nature of the calcified lesions studied, 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.

“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,” Shockwave Medical Chief Medical Officer Nick West, M.D., stated. “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.” 

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. 

Shockwave Medical Inc., part of Johnson & Johnson MedTech, develops and commercializes cardiovascular disease treatment products. Its IVL technology has transformed atherosclerotic cardiovascular disease treatment by safely using sonic pressure waves to disrupt challenging calcified plaque, resulting in significantly improved patient outcomes. Its Reducer technology—under clinical investigation in the United States and CE Marked in the European Union and the United Kingdom—is designed to provide relief to patients suffering from refractory angina by redistributing blood flow within the heart.

Johnson & Johnson’s cardiovascular portfolio provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation that address conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. The company’s cardiovascular arm focuses on heart recovery, circulatory restoration, heart rhythm disorder treatments, and neurovascular care.  

Johnson & Johnson’s expertise in innovative medicine and medtech positions the company to innovate across the full spectrum of healthcare solutions. The MedTech division boasts deep expertise in cardiovascular, orthopedics, surgery, and vision solutions. 

† Dr. Corl is a paid consultant for Shockwave Medical.

References
¹ https://www.cdc.gov/heart-disease/about/peripheral-arterial-disease.html
² https://www.nhlbi.nih.gov/health/peripheral-artery-disease
³ https://www.ahajournals.org/doi/full/10.1161/CIRCOUTCOMES.120.007539