Avinger receives FDA clearance for OCT-driven intravascular catheter
Avinger has received FDA clearance for its Ocelot catheter, a system driven by optical coherence tomography (OCT) to enable physicians to see inside an artery during a procedure in real time.
Avinger (Redwood City, CA) has received FDA clearance for its Ocelot catheter, a system driven by optical coherence tomography (OCT) to enable physicians to see inside an artery during a procedure in real time.
The Ocelot catheter targets periphery artery disease (PAD), which 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,” explains John B. Simpson, Ph.D., MD, Avinger's founder and CEO.
The company enrolled 122 patients from both Europe and the US in its CONNECT II global clinical trial in June 2012, during which the Ocelot catheter demonstrated 97% chronic total occlusion (CTO) crossing success with a 98% freedom from major adverse events (MAEs). The positive results of the trial led to the FDA clearance.
The Ocelot catheter, supported by the company's Lightbox OCT console, allows physicians to see from inside an artery during the actual procedure. In the past, operators have had to rely solely on x-ray as well as touch and/or feel to guide catheters through complicated blockages.
For more information, please visit http://avinger.com/ocelot.
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