AngioPlex OCT Angiography has received 510(k) clearance from the FDA, Zeiss Medical Technology announced in a press release.
This is the first OCT-angiography technology to be cleared in the U.S., Zeiss said.
Using the Cirrus HD-OCT system, AngioPlex requires only a single additional scan to provide high-resolution, depth-resolved visualization of the layers of the retinal and choroidal vasculature without an injected contrast dye, the release said.
“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,” Carmen A. Puliafito, MD, MBA, a co-inventor of OCT and OSN Retina/Vitreous Section Editor, said in the release. “This unique capability promises to revolutionize clinical decision making in retinal pharmacotherapy.”
To assess treatment efficacy and monitor disease progression, AngioPlex uses FastTrac to eliminate eye motion and enable follow-up OCT angiography images to be acquired at the same location. The system is powered by optical microangiography algorithms, an image processing technique used to provide high-quality OCT angiography images.
CE mark for AngioPlex in the European Union is pending, the release said.