Avinger, a medical device manufacturer of multifunctional catheters, has enrolled first the European patient, in Italy, for the CONNECT II global clinical trial.
The prospective multicentre non-randomised global CONNECT II clinical study is designed to assess the safety and efficacy of Ocelot in treating peripheral artery disease (PAD) in patients with femoropopliteal chronic total occlusion (CTO).
CE marked, Ocelot is designed for crossing completely blocked arteries or CTOs in the legs while simultaneously using optical coherence tomography (OCT) to visualise inside the arteries.
The Ocelot utilises real-time OCT imaging as a navigation tool to traverse completely blocked arteries precisely where needed, in order to restore blood flow back to normal.
Avinger founder and CEO John Simpson said Ocelot and CONNECT II is the first step towards incorporating intravascular imaging into therapeutic catheters for the treatment of vascular disease and amputation prevention.
Dr. Bernhard Reimers of Ospedale di Mirano in Mirano, Italy, said with Ocelot’s first-ever advanced imaging technology, physicians treating PAD can see, in real-time, the intricacies of what they are doing inside blocked arteries of patients.
"I am a part of this trial because this new technology provides us a more scientific and controlled way to treat peripheral arterial disease," Reimers added.
"This disease, if left untreated, often leads to amputation and death, but with Ocelot we believe many of these patients can now be saved."
In January 2012, the company received conditional US Food and Drug Administration (FDA) approval to conduct the study. Co-principal investigators for the trial include Arne Schwindt of St. Franziskus Hospital in Muenster, Germany, and Matthew Selmon of Austin Heart Hospital in Austin, Texas, US.
Avinger develops next-generation catheter-based technologies for the treatment of PAD.