DUBLIN, Calif.--(BUSINESS WIRE)--ZEISS Medical Technology announces that its AngioPlex OCT Angiography is the first such technology to receive 510(k) clearance from the U.S. Food and Drug Administration (FDA).
With a single additional OCT scan that takes just seconds on the CIRRUS HD-OCT system from ZEISS, ophthalmologists can now utilize optical coherence tomography (OCT) images to assess the blood vessels (vasculature) of the retina at a depth and clarity never available before. AngioPlex OCT Angiography delivers high-resolution, depth-resolved visualization of the separate layers of the retinal and choroidal vasculature -- without the need for an injected contrast dye, as is standard with fluorescein angiography (FA).
The information provided by these images is clinically impactful, because progression of retinal diseases is often accompanied by changes in the vasculature of the eye. In age-related macular degeneration (AMD), diabetic retinopathy, central retinal vein occlusion and other vascular conditions, AngioPlex OCT Angiography can complement traditional FA and become a safe and efficient part of routine eye care, potentially enabling earlier detection and management of micro-progressions.
"OCT angiography ushers in a new era in the evaluation of the retina in diabetic retinopathy and macular degeneration," said Carmen Puliafito, MD, dean of the Keck School of Medicine of the University of Southern California and one of the co-inventors of OCT. "Retinal specialists will now be able to obtain high-resolution cross-sectional images of the macula coupled to the most detailed visualization of the retinal vasculature ever achieved. This unique capability promises to revolutionize clinical decision making in retinal pharmacotherapy."
AngioPlex OCT Angiography clearly visualizes blood flow by detecting motion of scattering particles, such as red blood cells, within sequential OCT B-scans performed repeatedly at the same location of the retina. Unlike other OCT angiography systems that require multiple OCT scans to generate one single OCT angiography image, CIRRUS HD-OCT with AngioPlex only requires a single additional OCT scan. The key to this is the real-time retinal tracking system, FastTrac™, which actively eliminates eye motion to provide motion-artifact-free images of the perfused retina. Equally important, FastTrac enables follow-up OCT angiography images to be acquired at the same precise location in order to assess treatment efficacy and monitor disease progression.
In addition, AngioPlex is powered by Optical Micro Angiography (OMAG) Algorithms to provide ultra-clear vascular images. OMAG is an image processing technique that takes full advantage of not only amplitude but also phase OCT signal data to deliver the highest-quality OCT angiography images.
AngioPlex OCT Angiography is available on the CIRRUS 5000 HD-OCT platform , allowing ophthalmic practices the flexibility to easily integrate vascular imaging with standard OCT diagnostic imaging.
“We are pleased to provide U.S. doctors with a single OCT solution that allows them to make this revolutionary technology part of their daily clinical practice,” said Dr. Ludwin Monz, President and CEO of Carl Zeiss Meditec AG. “As the first such system cleared in the U.S., AngioPlex OCT Angiography continues a long tradition of ZEISS delivering innovations that help improve clinical decision-making and, ultimately, outcomes for patients.”
In addition to FDA clearance of AngioPlex, CE Marking is pending from the European Union.
Carl Zeiss Meditec AG
Carl Zeiss Meditec AG (ISIN: DE0005313704) is one of the world’s leading medical technology companies. The company supplies innovative technologies and application-oriented solutions designed to help doctors improve the quality of life of their patients. The company offers complete solutions, including implants and consumables, to diagnose and treat eye diseases. The company creates innovative visualization solutions in the field of microsurgery. Carl Zeiss Meditec's medical technology portfolio is rounded off by promising, future-oriented technologies such as intraoperative radiotherapy. In fiscal year 2013/2014 (ended 30 September) the company's around 2,900 employees generated revenue of EUR 909 million. Carl Zeiss Meditec headquarters are located in Jena, Germany.
The company has subsidiaries in Germany and abroad; more than 50 percent of its employees are based in the USA, Japan, Spain and France. The Center for Application and Research in India (CARIn) in Bangalore, India, and the Carl Zeiss Innovation Center for Research and Development in Shanghai, China, strengthen the company's presence in these rapidly developing economies. Around 35 percent of Carl Zeiss Meditec shares are in free float. The remaining 65% are held by Carl Zeiss AG, one of the world’s leading groups in the optical and optoelectronic industries.
In the markets for Industrial Solutions, Research Solutions, Medical Technology and Consumer Optics, Carl Zeiss has contributed to technological progress for more than 160 years and enhances the quality of life of many people around the globe. Carl Zeiss AG, Oberkochen, is fully owned by the Carl Zeiss Foundation.
For more information, please go to www.zeiss.com/med.