Heidelberg Engineering announces FDA clearance for its of its OCTA module

(Image credit: AdobeStock/MargJohnsonVA)

Heidelberg Engineering announced the FDA clearance of its Spectralis OCT angiography (OCTA) Module with SHIFT technology.

According to the company, this product reduces acquisition time by 50%.¹ The preset OCTA speed of 125 kHz is designed to help streamline workflow, enhance clinical efficiencies, and maintain Heidelberg image quality.

“While SPECTRALIS OCTA Module has always been a safe and cost-effective precursor to traditional angiography, delivering unparalleled resolution, many eye care practitioners have hesitated to fully adopt this advanced technology into daily clinical practice because of the acquisition time,” Ram Liebenthal, general manager USA at Heidelberg Engineering, said in a news release.

Leibenthal said the company is pleased to roll out the next generation of OCTA “that increases the acquisition speed without sacrificing image quality, thus making it a more versatile clinical tool in the diagnoses and management of retinal diseases.”

According to the company, the SHIFT technology combines a more powerful OCT engine, updated graphics processing technology, and software optimization to deliver speed, and maintain data integrity. The technology is available exclusively on third generation Spectralis devices.

Moreover, both the 85 kHz preset for structural OCT and the 125 kHz preset for OCTA allow eye care practitioners to complete their patient exams more efficiently. Furthermore, the 125 kHz OCTA image acquisition rate allows for visualization of flow, even in miniscule vessels, while minimizing artifacts, resulting in sharp and detailed images of the capillary network.

“Reducing the scanning time for OCTA without diminishing the resolution is a huge step forward, not only for Spectralis, but for the industry,” Dennis M. Marcus, MD, principal investigator of the clinical trial, said in the news release.

Marcus added that speed plus image quality eliminates the barriers and opens the door for mainstream adoption.

“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,” he concluded in the news release.

Reference:

1. Heidelberg Engineering Acquisition Time Comparison Video: SPECTRALIS with OCT2 Module at 85 kHz vs. SPECTRALIS with SHIFT Module at 125 kHz.