Heidelberg Engineering GmbH announced that the FDA has granted 510(k) clearance for the SPECTRALIS Optical Coherence Tomography-Angiography (OCTA) Module with SHIFT technology, designed to significantly reduce imaging acquisition time.
First up, this company.
Founded in 1991, the Baden-Württemberg, Germany-based Heidelberg Engineering is a high-tech imaging solutions company that designs, manufactures, and distributes ophthalmic diagnostic devices.
- See our recent coverage of the company.
Now SPECTRALIS.
SPECTRALIS is a non-contact ophthalmic diagnostic imaging platform featuring an upgradable (this is key), modular design that allows clinicians to “to configure each SPECTRALIS to the specific diagnostic workflow of a practice or clinic” by combining scanning laser fundus imaging with high-resolution OCT.
Its multimodal imaging options extends to:
- OCT
- Multiple scanning laser fundus imaging modalities
- Widefield and ultra-widefield
- Scanning laser angiography
- OCTA (our topic of interest)
These options are accessible via 10 SPECTRALIS modules, including glaucoma, multicolor, anterior segment, and widefield imaging.
And the SPECTRALIS OCTA Module?
The initial version of the SPECTRALIS OCTA Module was granted FDA 510(k) clearance in September 2018.
At the time, the new addition to the company’s multimodal platform of OCT retina imaging technology was said to allow “for the evaluation of retinal and choroidal vascular abnormalities in a noninvasive manner.”
- Note: The module was made available for current and new SPECTRALIS upgradeable diagnostic imaging devices.
Let’s move on to this SHIFT technology.
Originally introduced in March 2022, SPECTRALIS with SHIFT technology was launched as the first commercially available OCT that enabled clinicians to switch between three OCT scan speeds:
- 20, 85, and 125 kHz A-scan rates
Other features: full backward compatibility with existing patient data and functionality (for easy integration into existing clinical systems)
- The goal: For clinicians to provide customized approaches with patient-specific scan speeds for both increased efficiency and optimization.
Break down these scan speeds.
Get the full scoop here. Otherwise, here are the highlights from high to low A-scan rate:
- 125 kHz (preset scan speed for OCTA)
- Target purpose: allows for visualization of flow, even in miniscule vessels, while minimizing artifacts, resulting in sharp and detailed images of the capillary network
- 85 kHz (default scan speed)
- Target purpose: posterior segment for structural OCT analysis.
- 20 kHz (high-sensitivity OCT scan speed)
- Target purpose: to improve signal-to-noise ratio and help resolve details such as in the eyes with media opacities and small pupils
Now zero in on these two technologies together.
Important to note: The SPECTRALIS OCTA Module with SHIFT technology is reported to reduce image acquisition time by 50% while delivering OCTA images with a lateral resolution of 5.7 μm/pix.
- Plus: The OCTA preset speed of 125 kHz enables visualization of blood flow in fine capillaries while avoiding artifects (due to natural eye motion) and maintaining overall image quality, according to the company.
- Note: Both the 85 kHz preset for structural OCT and the 125 kHz preset for OCTA are intended to provide more efficient workflow process
So what else is new with this next generation of OCTA?
Heidelberg reported this module is equipped with “a more powerful OCT engine, updated graphics processing technology, and software optimization”—not to mention the increased speed, data integrity management, and performance improvement that the SHIFT technology brings.
Bonus: The “versatile clinical tool” is also (exclusively) available on third-generation SPECTRALIS devices via the OCT2 Module.
And how does this compare to the SPECTRALIS OCT2 Module?
Watch the video below for a side-by-side comparison.
Expert input on these capabilities?
“Reducing the scanning time for OCTA without diminishing the resolution is a huge step forward, not only for SPECTRALIS but for the industry,” stated Dennis M. Marcus, MD, principal investigator of a previous clinical trial (NCT04604002) involving the SPECTRALIS OCTA with SHIFT technology.
He added: “I think we will start to see more doctors warm to the idea of trying OCTA as part of the routine clinical work-up for at-risk patients.”
And lastly, where can I find this new offering?
Contact the company directly.