FDA Clears New Surgical Microscope From German Medtech Firm

The U.S. Food and Drug Administration has cleared for sale a new surgical microscope from Carl Zeiss Meditec AG that helps improve the imaging of certain anatomical details during eye surgery.

High-definition optical coherence tomography (OCT) images appear directly in the Lumera 700 microscope eyepiece, adding a real-time third dimension to visualization capabilities. Surgeons are provided improved views below the surface of the surgical field – enabling them to see more, even transparent structures in the anterior and posterior segment of the eye, the company said.

“Intraoperative OCT allows me to see things I could not see otherwise,” said Justis P. Ehlers, M.D., of Cleveland, Ohio, who has been using Rescan 700 on an investigational basis for nine months. “I use intraoperative OCT in most of my surgeries. We have found that real-time OCT feedback during surgery can improve our understanding of anatomy and impact surgical decision-making, particularly in membrane peeling cases and complex detachments — for example, proliferative diabetic retinopathy and proliferative vitreoretinopathy.”

The Rescan 700 helps surgeons concentrate more on the surgical procedure, as the necessary structural information known from pre-operative OCTs constantly is available intraoperatively. Additionally, the continuous OCT scanning supports achieving better patient outcomes because the surgeon can monitor progress and verify results during the procedure, Zeiss bigwigs noted in a news release.

“One of the great features of the Rescan 700 is the foot pedal control of the OCT beam – I can rapidly place it right where I need it during the surgery,” said Ehlers, the lead investigator for a prospective study with more than 200 cases examining microscope-integrated OCT and ophthalmic surgery. “And the Z-tracking feature enables improved stability of the OCT image during surgery-induced motion.”

OCT scans also can be stored and recalled for review. That way the new device enables better decision-making during surgery. “As a surgeon, I appreciate the confirmation of my surgical objectives that intraoperative OCT provides,” Ehlers said. “I receive guidance for where it’s optimal to start surgical maneuvers, and then subsequent feedback on whether I have accomplished the surgical objectives.”

Rescan 700 is useful for various surgeries in the anterior and posterior segment of the eye with a broad range of potential applications, the company contends.

“We are happy that now U.S. surgeons can also benefit from this new visualization technology and its potential to help them improve patient outcomes,” said Ludwin Monz, Ph.D., president/CEO of Carl Zeiss Meditec AG. “The merging of two of our gold standards into one system creates vast possibilities for changing ophthalmic surgery and expanding the capabilities of surgeons, especially for retina and cornea procedures.”

Carl Zeiss Meditec AG, listed on TecDAX of the German stock exchange, develops eye disease diagnosis and treatment technologies, including implants and consumable materials. Based in Jena, Germany, the company operates subsidiaries in Germany and at least a half-dozen foreign countries (China, France, India, Japan, Spain and the United States). Roughly 65 percent of Carl Zeiss Meditec shares are held by Carl Zeiss AG, a wholly owned subsidiary of the Carl Zeiss Foundation.