RESCAN 700 cleared for sale in the United States

RESCAN 700, the integrated intraoperative optical coherence tomography (OCT) system from Zeiss, has been cleared for sale in the United States by the Food and Drug Administration.

 

High-definition OCT images appear directly in the LUMERA 700 microscope eyepiece, adding a real-time third dimension to the visualization capabilities. Surgeons are provided unprecedented 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.

 

“Intraoperative OCT allows me to see things I could not see otherwise,” said Justis P. Ehlers, MD, 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.”

 

ZEISS RESCAN 700 helps surgeons to concentrate more on the surgical procedure, as the necessary structural information known from pre-operative OCTs is available all the time intraoperatively. Additionally, the continuous OCT scanning supports achieving better patient outcomes because the surgeon can monitor progress and verify results during the procedure.

 

“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 Dr. Ehlers, who has been 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 can also 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,” Dr. 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. “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 Dr. Ludwin Monz, president and 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.”