Sam Brusco, Associate Editor03.14.23
Shockwave Medical, a pioneer in development of intravascular lithotripsy (IVL) to treat severely calcified cardiovascular disease, began full U.S. launch of its Shockwave L6 peripheral IVL catheter following U.S. Food and Drug Administration (FDA) clearance.
The Shockwave L6 catheter modifies calcification in otherwise difficult-to-treat lesions in large peripheral vessels, including the iliac and common femoral arteries.
“The Shockwave L6 catheter pushes the boundaries of what IVL can help physicians achieve for patients with severe peripheral arterial disease,” Frank Arko, MD, Chief of Vascular and Endovascular Surgery at Carolinas Medical Center, Sanger Heart and Vascular Institute, told the press. “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 catheter has a compact emitter configuration and four new device sizes (8, 9, 10, and 12 mm diameters) that enable sonic pressure wave delivery in larger vessels. Shockwave L6 boosts the company’s peripheral IVL portfolio, extending 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, CEO 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.”
Shockwave Medical began an up to $147 million deal to acquire Neovasc, a developer of minimally invasive devices to treat refractory angina, in January of this year.
The Shockwave L6 catheter modifies calcification in otherwise difficult-to-treat lesions in large peripheral vessels, including the iliac and common femoral arteries.
“The Shockwave L6 catheter pushes the boundaries of what IVL can help physicians achieve for patients with severe peripheral arterial disease,” Frank Arko, MD, Chief of Vascular and Endovascular Surgery at Carolinas Medical Center, Sanger Heart and Vascular Institute, told the press. “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 catheter has a compact emitter configuration and four new device sizes (8, 9, 10, and 12 mm diameters) that enable sonic pressure wave delivery in larger vessels. Shockwave L6 boosts the company’s peripheral IVL portfolio, extending 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, CEO 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.”
Shockwave Medical began an up to $147 million deal to acquire Neovasc, a developer of minimally invasive devices to treat refractory angina, in January of this year.