Shockwave Medical has announced the global commercial availability of the Shockwave M5+ peripheral intravascular lithotripsy (IVL) catheter after receiving both CE mark and US Food and Drug Administration (FDA) clearance.
A company press release details that the Shockwave M5+ catheter 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 (Miriam and Rhode Island Hospitals, Providence, USA), 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 optimised 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 135cm, and a new, larger 8mm size, the company communicates. 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, iliofemoral, popliteal, infrapopliteal, 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 Medical advises that the M5+ catheter is now commercially available in Europe and the USA.