TrueVision system earns 510(k) clearance for image-guided ophthalmic surgery

TrueVision Systems, Inc. received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TrueVision 3D Visualization and Guidance System, which combines the 3D Visualization System running TrueWare 3D Imaging OS with the Refractive Cataract Toolset. It provides computer-aided surgical guidance to the surgeon during procedures such as corneal limbal relaxing incisions (LRI) to correct astigmatism, capsulorhexis, and toric intraocular lens (IOL) positioning. Pre-operative and post-operative 3D image capture is also enabled using the TrueVision platform in conjunction with slit-lamp biomicroscopes in the clinical setting for surgical planning.

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The TrueVision 3D Visualization and Guidance System provides computer-aided surgical guidance in real-time. 

Launched in 2008, the TrueVision 3D Visualization System is a stereoscopic 3D high-definition visualization system that displays the surgical field of view in real-time on a 3D flat-panel display in the operating room. This allows the surgeon to operate in a “heads-up” manner by looking at a large screen rather than through the traditional microscope oculars, providing better ergonomics and a more immersive visualization experience for the surgeon. The system is also used to record 3D surgical video for educational purposes and presenting on-demand and streaming 3D surgical video content at medical meetings.

“This groundbreaking innovation is the first of its kind representing a new generation of computer guidance tools for interactive surgery,” said Forrest Fleming, chief executive officer. “We are very encouraged by what our initial clinical studies have shown using on-screen guidance for several important aspects of refractive cataract surgery.”

“By using virtual guidance on the 3D live image, I can custom-tailor a capsulorhexis and limbal relaxing incision to the patient’s eye," said Mark Packer, MD, FACS, CPI, a clinical associate professor at Oregon Health & Science University. "The toolset software places virtual landmarks on the live surgical view that show appropriate incision arcs that appear on the limbus for correcting astigmatism. For the first time, I can accurately guide my surgery based on the pre-operative data. I don’t have to worry about ink marks because the guidance templates show precise axis, alignment and centration.”

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Posted by Lee Mather

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