Shockwave Medical Announces U.S. Launch of Shockwave L6 IVL Catheter to Treat Severely Calcified Peripheral Arterial Disease
Shockwave Medical, Inc., a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, recently announced the full U.S. commercial availability of the Shockwave L6 Peripheral IVL Catheter following clearance by the U.S. Food and Drug Administration (FDA).[0] The Shockwave L6 catheter is designed to modify calcification in large peripheral vessels like the iliac and common femoral arteries, which are associated with decreased procedural success and increased complications with standard endovascular techniques.[1]
The Shockwave L6 IVL catheter has a small emitter design, and it is now available in four new sizes (8.0, 9.0, 10.0 and 12.0 millimeter diameters). This makes it possible to effectively deliver sonic pressure waves in larger vessels.[0] The Shockwave L6 adds to the range of IVL peripherals available from the company, providing physicians with a selection of catheters that are tailored to the specific needs of infrapopliteal, femoropopliteal and iliac arterial territories. This selection is in addition to the Shockwave M5+ and Shockwave S4 catheters.[1]
The device is expected to minimize the risks of rupture and dissection, and is believed to be beneficial when utilized to facilitate transfemoral access for large bore procedures like Transcatheter Aortic Valve Replacement (TAVR), Thoracic Endovascular Aortic Repair (TEVAR) and Endovascular Aortic Repair (EVAR).[0]
Frank Arko, M.D., Chief of Vascular and Endovascular Surgery at Carolinas Medical Center, Sanger Heart and Vascular Institute in Charlotte, North Carolina, stated that the Shockwave L6 catheter is pushing the boundaries of what interventional vascular (IVL) therapy can help physicians to accomplish for patients with severe peripheral arterial disease. This new catheter presents features that enable physicians to optimize intravenous lumen (IVL) therapy in larger peripheral vessels, which account for more than one-fifth of all peripheral interventions done in the United States annually. The Shockwave L6 catheter has the potential to be advantageous when IVL is utilized to create a transfemoral access point for larger treatments including TAVR, TEVAR, and EVAR with the purpose of reducing the likelihood of rupture or dissection.
0. “Shockwave Medical announces US launch of new peripheral IVL …” vascularnews.com, 17 Mar. 2023, https://vascularnews.com/shockwave-medical-announces-us-launch-of-new-peripheral-ivl-catheter/
1. “Shockwave Medical Announces U.S. Launch of New Peripheral” www.globenewswire.com, 17 Mar. 2023, https://www.globenewswire.com/news-release/2023/03/14/2626573/0/en/Shockwave-Medical-Announces-U-S-Launch-of-New-Peripheral-IVL-Catheter.html
