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Shockwave Announces Commercial Availability of Below-the-Knee IVL Catheter


Shockwave Announces Commercial Availability of Below-the-Knee IVL Catheter


Shockwave S4 Catheter Expands the Intravascular Lithotripsy System Portfolio to Address the Challenges of Critical Limb Ischemia

Santa Clara, Calif. — November 4, 2019 — Shockwave Medical, Inc., a pioneer in the development of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, today announced commercial availability of the Shockwave S4 Peripheral IVL Catheter in select approved geographies. Shockwave S4 is a low-profile catheter specifically designed to access and treat challenging calcified lesions in below-the-knee (BTK) arteries that are frequently associated with critical limb ischemia (CLI), a serious condition associated with significant morbidity and mortality. Many patients with CLI do not respond well to endovascular treatment, especially when calcium is present, often requiring repeat procedures or even limb amputation. 

“The novel Shockwave S4 IVL catheter has the potential to change the treatment paradigm for our most difficult-to-treat patients – those with non-healing ulcers and wounds on their lower limbs due to lack of sufficient blood flow which we call Critical Limb Ischemia or CLI,” said Dr. George Adams, M.D., of UNC REX Health in Raleigh, NC, one of the first US physicians to use the new device. “IVL offers great promise as outcomes in patients with CLI remain poor, particularly for those who have significant, difficult to treat calcification of the small arteries below-the-knee.”

IVL is an innovative therapy designed to treat calcified artery stenoses with lithotripsy—sonic pressure waves historically used to treat patients with kidney stones. The technology minimizes trauma within the artery by delivering pulsatile sonic pressure waves locally that fracture calcium inside the artery wall but pass through surrounding soft vascular tissue in a safe manner.

Shockwave S4 complements the existing larger-diameter Shockwave M5 IVL catheter, which has been available in the U.S. since 2017 for the treatment of calcified peripheral artery disease. Shockwave S4features many design modifications to enhance deliverability in small, distal vessels of the legs, including a longer, hydrophilic shaft, a lower crossing profile, and a lower tip profile.

“We are committed to optimizing IVL for specific patient populations and anatomies, and one of the most challenging is patients with below-the-knee disease suffering from CLI,” said Doug Godshall, Chief Executive Officer of Shockwave Medical. “We look forward to continuing to roll out Shockwave S4 over the coming months to provide our customers with a tool that we hope will help them achieve a high degree of luminal gain with decreased vessel recoil and minimal complications with the ultimate goal of reducing the frequency of amputation.”

About Shockwave Medical, Inc.

Shockwave Medical is focused on developing and commercializing products intended to transform the way calcified cardiovascular disease is treated. We aim to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through our differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque, which we refer to as Intravascular Lithotripsy. IVL is a minimally invasive, easy-to-use and safe way to significantly improve patient outcomes. To view an animation of the IVL procedure and for more information, visit

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