Catheter for CTOs cleared for sale in US

REDWOOD CITY, CA – Avinger, Inc. has announced that the US Food and Drug Administration (FDA) has cleared for sale its Ocelot System, a multifunctional catheter for crossing chronic total occlusions (CTOs) in patients with Peripheral Artery Disease (PAD).

“It has taken my entire career to get to this moment,” said John B. Simpson Ph.D., M.D., Avinger founder and CEO. “Incorporating intravascular OCT into therapeutic devices has been the biggest priority here at Avinger. We have amazing investors who have allowed us to demonstrate how revolutionary Avinger can be. I’m so proud of our employees, all the physicians and hospitals around the world that helped us bring this amazing technology to the patients in the US.”

PAD affects between eight and twelve million adults in the US and 30 million people globally. The disease is caused by a plaque build-up in the arteries, blocking blood flow to the legs and feet. According to Dr. Simpson, recommended solutions are bypass surgeries and amputations, which can be avoided with the new device.

The Ocelot system allows physicians to see from inside an artery during the actual procedure using optical coherence tomography (OCT). The device is used in combination with the Lightbox, a mobile dual display imaging unit for the delivery of OCT images.