Leica Microsystems has received an FDA 510(k) clearance for the Leica FL800, an intra-operative video angiography device for the viewing of blood flow in the cerebral vascular area using Akorn ICG.
This is the only FDA (U.S. Food and Drug Administration) clearance for video angiography in the cerebral vascular area using ICG (IndoCyanine Green) as a fluorescent agent.
Surgeons with experience in vascular fluorescence have commented that the goal of ICG fluorescence lies in the quick and easy visualization of blood flow, which subsequently enables the surgeon to determine the permeability of vessels and effects of their surgery while they are operating through the Leica surgical microscope. Surgeons at a recent Congress of Neurosurgery in Chicago commented that real time vascular fluorescence is the biggest advance in intra-operative vascular neurosurgery in years.
The Leica FL800 fluorescence system is designed as a combination of an excitation light system, an ICG fluorescent agent, and a near infra-red camera to achieve the result. The FDA 510(k) clearance for the Leica FL800 was limited to the Akorn ICG, Leica surgical microscopes, and to the cerebral vascular area. Leica Microsystems may consider additional application extensions to its FDA clearance in the future.
The Leica FL800 vascular fluorescence procedure is quite simple for the surgeon to perform. The ICG agent is injected intravenously and the surgeon presses one button. The special NIR camera than picks up the fluorescent signal and displays it to the surgeon in real time. In addition the Leica FL800 records the imaging as a special loop so the surgeon can repeat the image later in surgery. This procedure can be repeated six times in a single surgery so the surgeon can track the effects of his surgical procedure on blood flow in the brain.
Each person who wants to market Class I, II and some III devices intended for human use in the U.S. must submit a 510(k) to FDA at least 90 days before marketing unless the device is exempt from 510(k) requirements. A 510(k) is a premarketing submission made to FDA (U.S. Food and Drug Administration), to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval. In case of clearance the device can be legally marketed in the US.