Shockwave Launches S4 Lithotripsy Catheter for BTK Arteries

November 4, 2019—Shockwave Medical, Inc. announced the commercial availability of the Shockwave S4 peripheral intravascular lithotripsy (IVL) catheter in select regions.

The Shockwave S4 is a low-profile catheter designed to access and treat calcified lesions in below-the-knee arteries that are frequently associated with critical limb ischemia (CLI). The technology aims to minimize trauma within the artery by locally delivering pulsatile sonic pressure waves that fracture calcium inside the artery wall but pass through surrounding soft vascular tissue in a safe manner.

According to the company, the Shockwave S4 complements the existing larger-diameter Shockwave M5 IVL catheter, which has been available in the United States since 2017 for the treatment of calcified peripheral artery disease. The S4 iteration includes design modifications to enhance deliverability in small, distal lower extremity vessels, including a longer, hydrophilic shaft and lower crossing and tip profiles.

George Adams, MD, of UNC Rex Health in Raleigh, North Carolina, commented in the company’s announcement, “The novel Shockwave S4 IVL catheter has the potential to change the treatment paradigm for our most difficult-to-treat patients—those with nonhealing ulcers and wounds on their lower limbs due to lack of sufficient blood flow which we call critical limb ischemia or CLI. 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.”