Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Real Time Vascular Fluorescence a Big Advance in Intra-Operative Vascular Neurosurgery

20.10.2006
Leica Microsystems Has Received an FDA 510(k) Approval for the Leica FL800 Intra-Operative Video Angiography Device

Leica Microsystems has received an FDA 510(k) approval 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) approval 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 them 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) approval 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 approval 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 approval the device can be legally marketed in the US.

Leica Microsystems is a leading global designer and producer of innovative, high-tech, precision optical systems for the analysis of microstructures. It is one of the market leaders in each of its business areas: Microscopy, Confocal Laser Scanning Microscopy, Imaging Systems, Specimen Preparation and Medical Equipment. The company manufactures a broad range of products for numerous applications requiring microscopic imaging, measurement, and analysis. It also offers system solutions for life science including biotechnology and medicine, research and development of raw materials, and industrial quality assurance. The company is represented in over 100 countries with 8 manufacturing facilities in 6 countries, sales and service organizations in 19 countries and an international network of dealers. With its workforce of about 3,200 employees it made turnover of US$ 597m in 2005. The international management is headquartered in Wetzlar, Germany.

Mylène Alt | Leica Microsystems
Further information:
http://www.leica-microsystems.com
http://www.akorn.com

More articles from Medical Engineering:

nachricht New technique to treating mitral valve diseases: First patient data
22.08.2017 | Universitätsspital Bern

nachricht New bioimaging technique is fast and economical
21.08.2017 | Rensselaer Polytechnic Institute

All articles from Medical Engineering >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Fizzy soda water could be key to clean manufacture of flat wonder material: Graphene

Whether you call it effervescent, fizzy, or sparkling, carbonated water is making a comeback as a beverage. Aside from quenching thirst, researchers at the University of Illinois at Urbana-Champaign have discovered a new use for these "bubbly" concoctions that will have major impact on the manufacturer of the world's thinnest, flattest, and one most useful materials -- graphene.

As graphene's popularity grows as an advanced "wonder" material, the speed and quality at which it can be manufactured will be paramount. With that in mind,...

Im Focus: Exotic quantum states made from light: Physicists create optical “wells” for a super-photon

Physicists at the University of Bonn have managed to create optical hollows and more complex patterns into which the light of a Bose-Einstein condensate flows. The creation of such highly low-loss structures for light is a prerequisite for complex light circuits, such as for quantum information processing for a new generation of computers. The researchers are now presenting their results in the journal Nature Photonics.

Light particles (photons) occur as tiny, indivisible portions. Many thousands of these light portions can be merged to form a single super-photon if they are...

Im Focus: Circular RNA linked to brain function

For the first time, scientists have shown that circular RNA is linked to brain function. When a RNA molecule called Cdr1as was deleted from the genome of mice, the animals had problems filtering out unnecessary information – like patients suffering from neuropsychiatric disorders.

While hundreds of circular RNAs (circRNAs) are abundant in mammalian brains, one big question has remained unanswered: What are they actually good for? In the...

Im Focus: RAVAN CubeSat measures Earth's outgoing energy

An experimental small satellite has successfully collected and delivered data on a key measurement for predicting changes in Earth's climate.

The Radiometer Assessment using Vertically Aligned Nanotubes (RAVAN) CubeSat was launched into low-Earth orbit on Nov. 11, 2016, in order to test new...

Im Focus: Scientists shine new light on the “other high temperature superconductor”

A study led by scientists of the Max Planck Institute for the Structure and Dynamics of Matter (MPSD) at the Center for Free-Electron Laser Science in Hamburg presents evidence of the coexistence of superconductivity and “charge-density-waves” in compounds of the poorly-studied family of bismuthates. This observation opens up new perspectives for a deeper understanding of the phenomenon of high-temperature superconductivity, a topic which is at the core of condensed matter research since more than 30 years. The paper by Nicoletti et al has been published in the PNAS.

Since the beginning of the 20th century, superconductivity had been observed in some metals at temperatures only a few degrees above the absolute zero (minus...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Call for Papers – ICNFT 2018, 5th International Conference on New Forming Technology

16.08.2017 | Event News

Sustainability is the business model of tomorrow

04.08.2017 | Event News

Clash of Realities 2017: Registration now open. International Conference at TH Köln

26.07.2017 | Event News

 
Latest News

Cholesterol-lowering drugs may fight infectious disease

22.08.2017 | Health and Medicine

Meter-sized single-crystal graphene growth becomes possible

22.08.2017 | Materials Sciences

Repairing damaged hearts with self-healing heart cells

22.08.2017 | Life Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>