Avinger, a medical device manufacturer, received approval from the United States Food and Drug Administration for its Ocelot System. The Ocelot System is a specialized multi-function catheter designed to assist surgeons in navigating chronic total occlusions (CTOs).
CTOs are often seen in patients with severe peripheral artery disease (PAD). The Ocelot System uses optical coherence tomography imaging to assist physicians and other healthcare providers during surgery. With the system, a surgeon can see the inside of a patient’s artery during an operation. The imaging system is designed for concurrent use with traditional fluoroscopy imaging systems.
The Ocelot System can help facilitate the intraluminal placement of traditional surgical guidewires in areas beyond the stenoic regions in the peripheral areas of an artery. This allows easier placement before percutaneous intervention.
The system is designed for use with the Lightbox, an imaging unit. The FDA approval of the company’s product follows a clinical trial comprising 122 patients in the U.S. and Europe. According to data from the clinical trial, the Ocelot System was able to demonstrate a CTO crossing success rate of 97 percent. In addition, the system demonstrated a 2 percent rate of major adverse events. The Ocelot System also received CE Mark approval in the European Union in September of 2011.