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Leica gets FDA clearance for brain blood flow imager

30 Aug 2017

Combination of fluorescein and microscope filter should help neurosurgeons see smaller blood vessels more clearly.

Germany-based Leica Microsystems says that it has received clearance from the US Food & Drug Administration (FDA) for a new microscope filter that should help brain surgeons see blood vessels more clearly.

The “FL560” fluorescence microscope filter aids visualization of cerebrovascular blood flow, when used in conjunction with fluorescein dye. It is said to provide better visualization of small blood vessels in particular, by providing a simultaneous view of blood flow in white-light and fluorescent illumination.

“When integrated into a M530 OH6 neurosurgical microscope, FL560 fluorescence provides real-time, high-contrast visualization of both cerebral anatomy in native color and fluorescent blood flow,” Leica claims. “With this combined view, the surgeon has more information to aid assessment and decision-making during vascular neurosurgery.”

Clinically relevant
Leica Mircosystems president Markus Lusser said in a company release: “I am proud that our team again was able to be the innovation leader by being the first company to achieve FDA clearance for cerebrovascular fluorescence imaging with fluorescein (FL560).

“This demonstrates our commitment to deliver clinically relevant and validated solutions to clinicians that allow them to make crucial surgical decisions and as a result improve patient outcomes.”

Leica states that it can be difficult for surgeons to assess cerebral anatomy and vascular flow under white light or with traditional near-infrared fluorescence that only provides a black and white image - particularly for smaller vessels and the areas they perfuse.

“By integrating the FL560 fluorescence filter into the M530 OH6 neurosurgical microscope, the surgeon is able to view anatomical structures in white-light and fluorescent blood flow simultaneously in the oculars,” adds the Wetzlar-headquartered company.

“This is achieved by combining premium microscope optics and illumination with a sophisticated, proprietary fluorescence filter design that effectively separates fluorescence excitation light and the observation spectrum. The result is a high-contrast image where anatomy is clearly visible and even the smallest vessels delineated.”

The advance is expected to help surgeons’ decision-making when operating on variety of neurovascular conditions, for example arteriovenous malformations (AVMs) – essentially a tangle of weakened blood vessels that are prone to bleeding - and aneurysms.

Optical innovation
Leica’s M530 OH6 neurosurgical microscopes feature optical innovations including the company’s “FusionOptics” technology. It provides two separate optical beam paths, one providing depth-of-field and the second a high-resolution image. The human brain is able to merge the two images to give surgeons an optimized view.

The M530 OH6 was also the first to feature the so-called “TriFluoro” technology, which enables a combination of fluorescence modules to be combined on a single microscope platform.

The surgical kit is based around a 400 Watt xenon lamp, apochromatic optics, and a laser spot for focusing.

Earlier this year Leica Microsystems revealed that it was working on a new generation of augmented reality (AR) fluorescence imaging technologies for surgical microscopes (see image on left).

Though not yet cleared for medical use, the “GLOW800” AR approach is said to combine high-contrast near-infrared fluorescence with white-light imaging in a single view – meaning that surgeons will not have to switch between those views.

“By overlaying the colored AR fluorescence image in the oculars, the surgeon has a more complete view of anatomical structures with no interruption or reorientation needed,” states the firm.

ULO OpticsSacher Lasertechnik GmbHDelta Optical Thin Film A/SDiffraction InternationalAltechnaEdmund OpticsSchaefter und Kirchhoff GmbH
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