Zeiss Announces First FDA 510(k) Clearance of OCT Angiography Technology

Source: Carl Zeiss Meditec

Tuesday, September 01, 2015 | FDA Approval/Clearance , , Carl Zeiss Meditec

Zeiss Medical Technology announced that it has received 510(k) clearance from the FDA for its AngioPlex OCT Angiography, the first such technology to receive clearance in the United States, according to a company news release

With a single additional OCT scan that takes 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.

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, according to Zeiss. In age-related macular degeneration (AMD), diabetic retinopathy, central retinal vein occlusion and other vascular conditions, AngioPlex OCT Angiography can complement traditional fluorescein angiography 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," Carmen Puliafito, MD, dean of the Keck School of Medicine of the University of Southern California and one of the co-inventors of OCT, said in the news release. "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 Algorithms to provide ultra-clear vascular images. Optical Micro Angiography Algorithms 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 US doctors with a single OCT solution that allows them to make this revolutionary technology part of their daily clinical practice,” Ludwin Monz, President and CEO of Carl Zeiss Meditec AG, said in a news release. “As the first such system cleared in the US, 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.


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