FDA Clears Avinger's Lightbox Touchscreen Vessel Measurement Function
December 22, 2016—Avinger, Inc. announced that the company has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Lightbox L250 imaging console. The company advised that new software will be made available to all existing L250 users at no cost and will be incorporated in all future Lightbox products as part of the standard software packages.
According to Avinger, the new FDA clearance allows the Lightbox L250 to provide a detailed measurement of vessels with a few simple taps on a touch screen, helping further improve visualization inside the vessel before, during, and after atherectomy procedures with the company's Pantheris Lumivascular system for the treatment of peripheral artery disease. Lumivascular technology allows physicians to see from inside the artery during a directional atherectomy procedure by using optical coherence tomography, which is displayed on the Lightbox console.
The enhanced technology also allows the clinician to create borders and measurements in seconds to determine the area of any vessel feature, automatically generate minimum and maximum diameters within a given area, and generate vessel size measurements for reference to facilitate adjunctive therapies. Users can also add and move reference points for even greater control, stated the company.
Sean Janzer, MD, commented in Avinger's press release, “The ability to obtain an accurate and real-time measurement from inside a diseased vessel is vital. It provides us key pieces of information that we can use to determine the levels of stenosis and luminal gain both during and immediately after an atherectomy procedure. Additionally, the measurements made possible by this latest upgrade will help optimize both the atherectomy and adjunctive therapies performed postatherectomy, such as the deployment of a drug-coated balloon or placement of a stent.” Dr. Janzer is an interventional cardiologist at Einstein Medical Center in Philadelphia, Pennsylvania.