The US Food and Drug Administration (FDA) has given Avinger approval to market its Ocelot System for the treatment of chronic total occlusions in patients with peripheral arterial disease.
Ocelot is the first-ever interventional chronic total occlusion crossing catheter to incorporate optical coherence tomography (OCT). This technology allows physicians to navigate and cross totally blocked arteries in the legs of patients suffering from peripheral arterial disease using a real-time cross-sectional image of the artery.
FDA approval was supported with results from the CONNECT II global clinical trial in which the Ocelot System demonstrated a chronic total occlusion crossing success of 97% with 98% freedom from major adverse events, indicating both the primary safety and efficacy endpoints were statistically met. A total of 122 patients from both Europe and the USA took part in the trial. Results of the study were presented at the VIVA conference in Las Vegas (9–12 October).
Avinger successfully completed enrolment in its CONNECT II global clinical trial in June 2012.
“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,” said John B Simpson, founder and CEO, Avinger.
Ocelot received CE mark in 2011.