Intuitive Surgical, Sunnyvale, Calif, has received FDA clearance for its Firefly Fluorescence Imaging technology, which provides enhanced visualization during minimally invasive surgical procedures. The technology has been available since 2011 as an optional feature on the da Vinci Si system, and will now ship with all da Vinci Xi systems.
The clearance marks the third major FDA approval for products supporting the da Vinci Xi system since its United States launch this past April. Previous clearances involved advanced technologies for sealing and stapling vessels. All technologies were previously cleared for use on the da Vinci Si system.
The Firefly Imaging System enables real-time visual assessment of vessels, blood flow, and related tissue perfusion, as well as the major ducts that connect to the gallbladder for transport of bile. This assessment is helpful during surgical removal of the gallbladder. The imaging technology enables surgeons to switch between standard, visible light and near-infrared imaging during minimally invasive procedures. When a surgeon uses the Firefly system in conjunction with an injectable fluorescent dye, tissue with blood flow appears green while tissue without blood flow appears gray. The technology is intended for biliary duct visualization in conjunction with standard, visible light in bile-duct imaging and x-ray examination of the bile ducts during surgery.
“With this latest clearance for the da Vinci Xi System, we’re fulfilling our promise of providing an expandable technology platform designed to accommodate and seamlessly integrate a range of current technologies in areas such as imaging, advanced instruments and anatomical access,” said Frank P. Grillo, vice president of marketing and business development for Intuitive Surgical. “This is a significant technology designed to enhance surgical performance by providing the surgeon with additional visualization capability during surgery, and we are very pleased to bring it to the Xiplatform.”
For more information, visit Intuitive Surgical.