Shockwave Medical today announced the full US commercial availability of the Shockwave L6 peripheral intravascular lithotripsy (IVL) catheter following clearance by the US Food and Drug Administration (FDA).
A press release details that 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.
“The Shockwave L6 catheter pushes the boundaries of what IVL can help physicians achieve for patients with severe peripheral arterial disease,” said Frank Arko (Sanger Heart and Vascular Institute, Charlotte, USA). “The characteristics of the new catheter allow physicians to optimise IVL therapy in large peripheral vessels, which represent over 20% of peripheral interventions performed in the USA each year. The Shockwave L6 catheter may also be beneficial when IVL is utilised to facilitate transfemoral access for large bore procedures like TAVR [transcatheter aortic valve replacement], TEVAR [thoracic endovascular aortic repair] and EVAR [endovascular aortic repair] to minimise the risks of rupture and dissection.”
According to Shockwave Medical, the L6 IVL catheter’s compact emitter configuration, in conjunction with four new device sizes (8, 9, 10 and 12mm diameters), enables effective delivery of sonic pressure waves in larger vessels.
“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.”