Shockwave Medical Launches M⁵⁺ Peripheral IVL Catheter Globally

March 31, 2022–Shockwave Medical, Inc., a developer of intravascular lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced that the Shockwave M⁵⁺ peripheral IVL has received both CE Mark and FDA clearance and is now commercially available.

According to the company, the Shockwave M⁵⁺ catheter incorporated customer feedback to improve IVL efficiency in tacking complex calcified lesions. With a cycle time that delivers two pulses per second, an increased catheter length of 135 cm, and a larger, 8-mm size, the catheter is designed to decrease IVL treatment time, provide alternative access options, and expand IVL therapy to patients with larger vessel sizes.

The catheter is intended for difficult-to-treat calcified lesions in the peripheral arterial system of the lower extremities (ie, iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries).

“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,” commented Peter Soukas, MD, in Shockwave’s press release.

He continued, “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.” Dr. Soukas is with Miriam and Rhode Island Hospitals in Providence, Rhode Island, and is one of the first physicians to use the new catheter.

Doug Godshall, Chief Executive Officer of Shockwave Medical, noted that the Shockwave M⁵⁺ launch is the next step in the company’s commitment to expanding the applicability of its technology for diverse patient populations and anatomies.