Shockwave Medical Launches L6 Peripheral IVL Catheter

March 14, 2023—Shockwave Medical, Inc., a developer of intravascular lithotripsy (IVL) for the treatment of severely calcified cardiovascular disease, announced the full United States commercial availability of the Shockwave L6 peripheral IVL catheter, which received 510(k) clearance from the FDA.

According to the company, the Shockwave L6 catheter is designed to modify calcification in difficult-to-treat lesions in large peripheral vessels, including the iliac and the common femoral arteries. The Shockwave L6 IVL catheter’s compact emitter configuration, in conjunction with four new device sizes (8-, 9-, 10-, and 12-mm diameters), enables the effective delivery of sonic pressure waves in larger vessels.

The device enhances the company’s peripheral IVL portfolio, extending the size offerings of the Shockwave M5+ and Shockwave S4 catheters, to provide physicians with a choice of catheters optimized for the challenges of infrapopliteal, femoropopliteal, and iliac arterial territories, stated the company.

“The Shockwave L6 catheter pushes the boundaries of what IVL can help physicians achieve for patients with severe peripheral arterial disease,” commented Frank Arko, MD, in the company’s press release. Dr. Arko is Chief of Vascular and Endovascular Surgery at Carolinas Medical Center, Sanger Heart and Vascular Institute in Charlotte, North Carolina.

Dr. Arko stated further, “The characteristics of the new catheter allow physicians to optimize IVL therapy in large peripheral vessels, which represent over 20% of peripheral interventions performed in the United States each year. The Shockwave L6 catheter may also be beneficial when IVL is utilized to facilitate transfemoral access for large-bore procedures like transcatheter aortic valve replacement, thoracic endovascular aortic repair, and endovascular aneurysm repair to minimize the risks of rupture and dissection.”