California-based medical device maker Avinger landed FDA clearance for its Ocelot | PIXL catheter system, the company’s 2nd FDA win in as many months.
In November Avinger won clearance to commercialize its Ocelot System, designed to help physicians see inside arteries to treat peripheral artery disease.
The new Ocelot | PIXL system allows physicians to navigate lesions with a choice between 135cm or 150cm working length and provides intravascular imaging at all times, according to the press release.
"With its smaller profile and longer length, Ocelot | PIXL is designed to bring all the benefits of Ocelot to help physicians treat more patients with smaller arteries," founder & CEO Dr. John Simpson said in prepared remarks. "Because Ocelot | PIXL, like the original Ocelot catheter, uses real-time intravascular imaging via optical coherence tomography, I’m confident more legs will be saved, and more patients will walk home happy."
The Ocelot catheter, supported by the company’s Lightbox imaging console, is designed with real-time optical coherence tomography to help operators accurately navigate through crossing chronic total occlusions.
The FDA last month cleared Avinger’s Ocelot System,which landed CE Mark in the European Union in September.