Leica gets FDA approval for novel neurosurgical microscopy filter
It is a proud moment for Leica Microsystems to be the first firm to get FDA 510(k) approval for its fluorescence microscope filter FL560 for cerebrovascular blood flow visualization in combination with the dye fluorescein. When incorporated into a neurosurgical microscope M530 OH6, FL560 fluorescence offers a high-contrast, real-time imaging of both fluorescent blood flow as well as cerebral anatomy in native color. With this collective view, the doctor has more data to help in decision-making and assessment at the time of vascular neurosurgery.
Assessing vascular flow and cerebral anatomy, specifically in smaller vessels and the regions they perfuse, can be tough with traditional near-infrared fluorescence or under white light. The traditional near-infrared fluorescence offers only a black and white picture. By incorporating the M530 OH6 neurosurgical microscope with FL560 fluorescence filter, the doctor is capable of viewing fluorescent blood flow and anatomical structures in white-light at the same time in the oculars. This is accomplished by uniting illumination and premium microscope optics with a proprietary, sophisticated fluorescence filter design that efficiently differentiates the observation spectrum as well as fluorescence excitation light. The result is a high-contrast picture where anatomy is evidently observable and even the tiniest vessels is outlined.
“Leica Microsystems has been a dominator in enhanced surgical visualization for years. We have accomplished a lot of ‘firsts’ over the decades comprising the first FDA 510(k) approval for intra-operative angiography (FL800) of a microscope and the first firm providing a surgical microscope to incorporate 3 kinds of fluorescence abilities (TriFluoro). I am proud that our group once more was capable of the innovation leader by being the first firm to gain FDA approval for cerebrovascular fluorescence visualization with fluorescein (FL560). This shows our pledge to give medically validated and relevant solutions to doctors that permit them to make critical surgical decisions and consequently enhance patient outcomes,” claims President Leica Microsystems, Markus Lusser, to the media.
FL560 fluorescence can help the visualization of a surgeon and simultaneously in surgical decisions for a diversity of neurovascular cases comprising aneurysms and Arteriovenous Malformations (AVM).
Leica Microsystems’ FL560 fluorescence has been developed to permit complete incorporation at any time into new or current M530 OH6 neurosurgical microscopes. The M530 OH6 microscope is the first tool to sport TriFluoro tech. This allows FL560 and 2 other kinds of fluorescence to be set up into a sole microscope. Complete incorporation also makes possible a smooth flow of work with single-touch activation of various fluorescence modes through wireless footswitch or microscope handgrip, further backing the surgical flow of work.