The FDA cleared Avinger’s Ocelot System, a medical device that allows physicians to see images from inside arteries in a treatment of peripheral artery disease.
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 company hopes the system will gain widespread use and prevent patients from needing bypass surgeries or amputations associated with PAD, according to a company statement.
“It has taken my entire career to get to this moment,” founder & CEO Dr. John Simpson said in prepared remarks. “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.”
Avinger completed its global clinical trial in June, which involved 122 patients from Europe and the U.S. Researchers concluded that 97% of the patients underwent successful CTO crossing and 98% were free from major adverse events.
The Avinger’s Ocelot catheter landed CE Marked in September.