Leica Microsystems receives FDA De Novo clearance for blue light fluorescence module

Leica Microsystems has received DeNovo clearance from the U.S. Food and Drug Administration (FDA) to market its FL400 surgical microscope filter in the United States for characterization of tumor tissue in neurosurgery.

In combination with the active substance 5 aminolevulinic acid (5-ALA), FL400 fluorescence allows surgeons to visually differentiate malignant glioma tissue from healthy brain tissue in real time. This aids precise tumor resection, which is vital in order to preserve brain function.

“For the past decade we’ve been pioneering new fluorescence imaging technologies in partnership with surgeons to advance surgical practices,” says Markus Lusser, President of Leica Microsystems.

“We’ve gathered strong clinical evidence for the efficacy of FL400 with 5-ALA by working closely with our surgical partners and with NX Development Corp. (NXDC), who license 5-ALA as GleolanTM in the US*. Leica Microsystems and NXDC are proud that we can now provide surgeons with another visualization tool to support decision-making in some of the most complex and critical neurosurgical interventions.”

The technology of the FL400 filter has been designed to provide intense, homogenous excitation light and a well-adjusted observation spectrum. When this is combined with a Leica neurosurgical microscope, such as the ARveo digital augmented reality microscope, surgeons benefit from real-time, bright, and high-contrast delineation of tumor margins.

FL400 mode can be activated with just a touch of the button and surgeons can choose to view tissue fluorescence in the oculars of the microscope or displayed on a large 4K 3D screen. This supports a smooth intra-surgical workflow as well as offering the option to operate “heads-up”.

With FL400, FL560, and GLOW800 fluorescence now cleared and integrated into the ARveo digital AR microscope, we are equipping health care providers with a comprehensive future-ready surgical imaging solution."

Maxim Mamin, VP, Medical Division

“In addition, the ARveo integrates Image Guided Surgery (IGS) data and endoscope imaging. This further augments the insights available to the surgeon during life-saving procedures.”

FL400 oncological fluorescence and GLOW800 AR vascular fluorescence can be experienced first-hand integrated into the ARveo digital AR microscope at the American Association of Neurological Surgeons (AANS) Annual Scientific Meeting 2019. The meeting will take place in San Diego, USA, from 14 to 17 April and Leica Microsystems can be found on booth 1733.

*NXDC is a trademark of NX Development Corp., Lexington, KY, USA. More detail on Gleolan can be found at www.gleolan.com.