Avinger has received a CE mark for Ocelot, a system that combines the use of its peripheral catheter designs incorporated with optical coherence tomography (OCT) for the treatment of peripheral artery disease (PAD).
Ocelot is a tool for accessing regions of the peripheral vasculature while providing OCT visualization for navigation through arteries, according to the Redwood City, Calif.-based company. Using Ocelot’s Lightbox console as an adjunct to fluoroscopy, medical professionals will have access to a therapeutic device that incorporates intravascular guidance.
Avinger is currently enrolling patients in the VISTA study, a single-center, non-randomized registry study designed to evaluate the safety and efficacy of Ocelot in patients with PAD. The principal investigator of this trial is Adrian A. Ebner, MD, of Sanitorio Italiano in Asunción, Paraguay. John B. Simpson, MD, PhD, CEO of Sequoia Hospital in Redwood City, Calif., and John P. Pigott, MD, vascular surgeon at Jobst Vascular Institute in Toledo, also participated in the first in man registry in Paraguay.
Commercialization of Ocelot in select European countries began Sept. 23. The first three commercial cases are scheduled to be performed in Italy and Germany in late September and early October.