Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, today 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). The Shockwave L6 catheter is purpose-built to modify calcification in otherwise difficult-to-treat lesions in large peripheral vessels, including the iliac and the common femoral arteries. Calcification in these arteries is common and associated with decreased procedural success and increased complications with standard endovascular techniques.1
“The Shockwave L6 catheter pushes the boundaries of what IVL can help physicians achieve for patients with severe peripheral arterial disease,” said Frank Arko, M.D., Chief of Vascular and Endovascular Surgery at Carolinas Medical Center, Sanger Heart and Vascular Institute in Charlotte, North Carolina. “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 U.S. each year. The Shockwave L6 catheter may also be beneficial when IVL is utilized to facilitate transfemoral access for large bore procedures like TAVR, TEVAR and EVAR to minimize the risks of rupture and dissection.”
The Shockwave L6 IVL catheter’s compact emitter configuration, in conjunction with four new device sizes (8.0, 9.0, 10.0 and 12.0 millimeter diameters), enables effective delivery of sonic pressure waves in larger vessels. The Shockwave L6 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.
“Shockwave L6 is another example of our team’s commitment to developing technologies to address specific market needs while still maintaining the safety, effectiveness and ease of use of our core IVL technology,” said Doug Godshall, Chief Executive Officer of Shockwave Medical. “We are pleased with the success of our limited release and the great feedback we have received from our customers. We now look forward to offering Shockwave L6 as an additional IVL option for the most complex and high-risk large vessel cases.”
