Intuitive Surgical Gets FDA OK for Imaging Add-On Technology for its Da Vinci Robots

Intuitive Surgical Inc., maker of robot-assisted minimally invasive surgery, received U.S. Food and Drug Administration clearance of its Firefly fluorescence imaging for the da Vinci Xi surgical system, which provides surgeons with enhanced visualization during minimally invasive surgical procedures. Firefly Imaging has been available since 2011 as an optional feature for the da Vinci Si system, and this clearance means that Firefly imaging will now ship with all da Vinci Xi Systems.

It is the FDA clearance for products supporting the da Vinci Xi system since its U.S. launch in April. The first and second clearances allow the company to market advanced technologies for vessel sealing and stapling for use with the da Vinci Xi system. All three technologies were previously cleared for use with the da Vinci Si system.

According to the company, the Firefly Imaging System enables real-time visual assessment of vessels, blood flow and related tissue perfusion. It also enables assessment of the major ducts that connect to the gallbladder for transport of bile, a digestive fluid. The assessment is helpful during surgical removal of the gallbladder. The Firefly System 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 is highlighted in a green color and tissue without blood flow appears gray in the surgeon’s view. The Firefly system is intended to be used for biliary duct visualization in conjunction with standard, visible light in bile-duct imaging and where indicated, 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, Intuitive Surgical’s vice president of marketing and business development. “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 Xi platform.”

In June, Intuitive Surgical FDA clearance for the EndoWrist One Vessel Sealer instrument for the da Vinci Xi System. The EndoWrist One Vessel Sealer is designed to enable sealing and cutting vessels up to 7 millimeters in diameter and tissue bundles that fit in the jaws of the instrument.

In July, Intuitive Surgical received FDA clearance for the EndoWrist Stapler 45 and white, blue and green reloads for use with the da Vinci Xi System. The EndoWrist stapler provides wristed articulation and feedback that detects if the stapler jaws are adequately closed on the tissue prior to firing. The EndoWrist stapler is intended for resection, transection and/or creation of anastomoses (surgical connections between vessels or tissues) in gynecologic, general, urologic and thoracic surgery. Thoracic surgery is a new indication for the EndoWrist stapler, as thoracic surgery is not part of the EndoWrist Stapler 45 indications for use for the da Vinci Si system.

Intuitive Surgical is headquartered in Sunnyvale, Calif.