FDA Approves Avinger Catheter

Avinger Receives Clearance to Market Ocelot | PIXL in the United States

December 28, 2012
Manufacturing Group
Assembly Materials People/Facilities

Avinger Inc., a medical device manufacturer of innovative, multi-functional imaging catheters for crossing chronic total occlusions (CTOs) in patients with Peripheral Artery Disease (PAD), has received FDA clearance to market Ocelot | PIXL in the United States. Just one month after receiving clearance to commercially sell the Ocelot System in the US, the first-ever CTO crossing device with onboard imaging, Avinger debuts its newest member of the Ocelot family.

“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,” says John B. Simpson PhD, MD, Avinger Founder and CEO. “Because Ocelot | PIXL, like the original Ocelot catheter, uses real-time intravascular imaging via optical coherence tomography (OCT), I’m confident more legs will be saved, and more patients will walk home happy.”

Using Ocelot | PIXL, physicians can now navigate lesions with a choice between 135cm or 150cm working length. With its five French sheath compatibility and reinforced distal coil for precise steerability, Ocelot | PIXL goes the extra distance with ease, providing intravascular imaging at all times. Like all Ocelot catheters, Ocelot | PIXL is supported by Avinger’s Lightbox console.