Shockwave Medical Announces Global Launch of New Peripheral Intravascular Lithotripsy Catheter

Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, today announced the global commercial availability of the Shockwave M⁵⁺ peripheral IVL catheter after receiving both CE Mark and U.S. Food and Drug Administration (FDA) clearance. The Shockwave M⁵⁺ catheter, which has been in limited launch until today, is specifically designed to decrease IVL treatment time, provide alternative access options, and expand IVL therapy to patients with larger vessel sizes.

“Shockwave’s new peripheral catheter offers remarkable improvements that enable efficient and effective treatment for some of our most difficult-to-treat patients, some of whom previously could not have been treated with IVL,” said Peter Soukas, M.D., of Miriam and Rhode Island Hospitals in Providence, Rhode Island, and one of the first physicians to use the new catheter. “While treating patients with long, severely calcified lesions will always be challenging, the new Shockwave catheter is appropriately sized for larger vessels and has been optimized to expand options for facilitating vessel access, all while decreasing the amount of time needed to perform IVL in the procedure.”

Shockwave M⁵⁺ incorporates valued customer feedback to improve IVL efficiency in tackling complex calcified lesions, including quicker cycle time that delivers two pulses per second, an increased catheter length of 135 centimeters, and a new, larger 8.0 millimeter size. The catheter is specifically designed to treat otherwise difficult-to-treat calcified lesions in the peripheral arterial system of the lower extremities, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries.

“The launch of Shockwave M⁵⁺ is the latest step in our commitment to expanding the applicability of our technology for more diverse patient populations and anatomies,” said Doug Godshall, Chief Executive Officer of Shockwave Medical. “After a very successful limited launch, we are enthusiastic about the global rollout of Shockwave M⁵⁺ and the ability to provide our customers with a new tool to advance treatment options – with the consistent reliability and simplicity of IVL that physicians have come to expect when treating patients with Shockwave IVL.”

Shockwave M⁵⁺ is now commercially available in Europe and the United States.

About Shockwave Medical, Inc.
Shockwave is focused on developing and commercializing products intended to transform the way calcified cardiovascular disease is treated. Shockwave aims to establish a new standard of care for the interventional treatment of atherosclerotic cardiovascular disease through differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque, which the company refers to as Intravascular Lithotripsy (IVL). IVL is a minimally invasive, easy-to-use and safe way to significantly improve patient outcomes.