Avinger earns CE mark approval for OCT catheter system
Avinger, Inc. (Redwood City, CA) garnered CE mark approval for its Ocelot catheter system, which incorporates real-time optical coherence tomography (OCT) and targets peripheral artery disease (PAD) treatment.
The Ocelot OCT catheter system can access discrete regions of the peripheral vasculature while simultaneously providing OCT visualization for navigation through arteries. Using Ocelot's Lightbox console as an adjunct to fluoroscopy, medical professionals will—for the first time—have access to a therapeutic device that incorporates real-time intravascular guidance.
Avinger recently returned from Paraguay, where it 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 Dr. Adrian Ebner of Sanitorio Italiano in Asuncion, Paraguay. Dr. John Simpson of Sequoia Hospital in Redwood City, CA, and Dr. John Pigott of Jobst Vascular Institute in Toledo, OH, also participated in this groundbreaking, first-in-man registry in Paraguay.
Commercialization of Ocelot in select European countries began on September 23, 2011. The first three commercial cases are scheduled to be performed in Italy and Germany in late September and early October. This marks a major step for the company in their commitment to providing patients with minimally invasive vascular disease treatment.
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