Avinger, Inc., a medical device manufacturer of innovative, multi-functional catheters for crossing chronic total occlusions (CTOs) in patients with Peripheral Artery Disease (PAD), announces its Ocelot System has been cleared for sale in the U.S. by the Food and Drug Administration (FDA).
"It has taken my entire career to get to this moment," said John B. Simpson PhD, MD, 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 is an unrecognized epidemic that affects between eight and 12 million adults in the U.S. and 30 million people globally. It is caused by a build-up of plaque in the arteries that blocks blood flow to the legs and feet. "Often times, bypass surgeries or amputations are the recommended solutions. Ocelot can help save patients from such dire circumstances and patients can be back on their feet in days," continued Dr. Simpson.
Patients walk out of the unknown
A total of 122 patients from both Europe and the U.S. took part in the Ocelot global clinical trial, the results of which led to today's FDA clearance. Available here are several stories, told by the Ocelot patients, their family members, friends, work colleagues, and the doctors and nurses who helped them. Here's a snapshot: