Heidelberg Engineering receives FDA clearance for spectral domain OCT

Vista, CA, and Heidelberg, Germany-The FDA has granted clearance for Heidelberg Engineering GmbH’s Spectralis HRA+OCT, said to be the first commercially available spectral domain (sometimes called Fourier domain) optical coherence tomograph (OCT) combined with laser angiography. The company expects to begin shipping the product in mid-2007.

At 40,000 scans per second, the spectral domain system is 100 times faster than time domain OCT, offering greater detail to reveal previously unseen retinal structures. The technology combines high-resolution cross-sectional images of the retina with any of four imaging modalities: autofluorescence, infrared, fluorescein angiography, or indocyanine green (ICG) angiography. Because the OCT and angiographic images are captured simultaneously, the clinician can be assured of the exact location of the area of interest and can correlate the outer visible retina structure with the internal structure.

“This new technology represents a dramatic leap in our ability to image complex macular disease,” said Scott Cousins, MD, director, Duke Center for Macular Diseases, Duke University, Durham, NC. “The combination of these two cutting-edge technologies will amplify our understanding of retinal structure and provide us with new insights into the biological processes of the retina.”

The new product is built on the company’s Heidelberg Retina Angiograph (HRA) platform, which uses lasers in combination with marker dyes such as sodium fluorescein and ICG. Using the angiography system instead of white light photography has allowed clinicians to capture detailed images of the blood vessel structure within the retina. Another advantage of using lasers is the fast frame rate, which enables movies of the blood flow, adding a new diagnostic dimension over traditional photography.

The company’s angiographic technology also can cause certain retinal components to fluoresce in a process known as autofluorescence. In the recently announced AREDS 2 clinical trial, geographic atrophy of age-related macular degeneration is being followed using autofluorescence as a potential early indicator of disease progression.