Avinger has received CE mark approval for Ocelot ‰Û¥ a peripheral catheter system used with real-time Optical Coherence Tomography (OCT) for the treatment of peripheral artery disease.
According to Avinger, medical professionals, for the first time ever, will have access to a therapeutic device that incorporates real time intravascular guidance by using Ocelot’s Lightbox console as an adjunct to fluoroscopy.
“Ocelot CE mark is a long anticipated milestone for Avinger and a much larger milestone for me professionally. I have been working on uniting intravascular guidance with therapeutic products for 30 years and I am humbled that we have been able to achieve this at Avinger,” said John B Simpson, Avinger’s founder and CEO.
Avinger is currently enrolling patients in the VISTA study ‰Û¥ a single-centre, non-randomised registry designed to evaluate the safety and efficacy of Ocelot in patients with peripheral artery disease. The registry is being developed in Paraguay, with Adrian Ebner of Sanitorio Italiano in Asunción, as the principal investigator.
European comercialisation of Ocelot has already begun. The first three commercial cases are scheduled to be performed in Italy and Germany in late September and early October.
