FDA Clears First Forward-Looking Imaging Catheter to Treat Chronic Total Occlusions
The Avinger Ocelot optical coherenace tomography (OCT) catheter helps cross chronic total occlusions (CTOs) in patients with peripheral artery disease (PAD). The Ocelot catheter, supported by the Lightbox console, allows physicians to see from inside an artery during the actual procedure using forward-looking OCT.
In the past, operators have had to rely solely on X-ray angiography and touch to guide catheters through complicated blockages. The current method makes for imprecise vessel navigation, leading to long procedure times and possible complications, such as vessel perforation. With Ocelot, physicians can more accurately navigate through CTOs thanks to the addition of imaging what is ahead of the catheter.
Avinger successfully completed enrollment in its CONNECT II global clinical trial in June 2012. The Ocelot System demonstrated a CTO crossing success of 97 percent with a 98 percent freedom from major adverse events (MAEs).
For more information: www.avinger.com