Intuitive Surgical Receives Firefly(TM) FDA Clearance for da Vinci(R) Xi(TM) Surgical System
This marks the third significant U.S.
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. This 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
For more information about Firefly Fluorescence Imaging and the da Vinci Xi Surgical System, visit intuitivesurgical.com.
About Intuitive Surgical, Inc.
About the da Vinci Surgical System
There are several models of the da Vinci Surgical System. The da Vinci Surgical Systems are designed to help doctors perform minimally invasive surgery. da Vinci Systems are not programmed to perform surgery on their own. Instead, the surgery is performed entirely by a doctor, who controls the system. da Vinci Systems offer doctors high-definition 3D vision, a magnified view, and robotic and computer assistance. They use specialized instrumentation, including a miniaturized surgical camera and wristed instruments (i.e., scissors, scalpels and forceps) that are designed to help with precise dissection and reconstruction deep inside the body.
Important Safety Information
Serious complications may occur in any surgery, including da Vinci Surgery, up to and including death. Risks include, but are not limited to, injury to tissues and organs and conversion to other surgical techniques. If your doctor needs to convert the surgery to another surgical technique, this could result in a longer operative time, additional time under anesthesia, additional or larger incisions and/or increased complications. Individual surgical results may vary. Patients who are not candidates for non-robotic minimally invasive surgery are also not candidates for da Vinci Surgery. Patients should talk to their doctors to decide if da Vinci Surgery is right for them. Patients and doctors should review all available information on non-surgical and surgical options in order to make an informed decision. Please also refer to www.daVinciSurgery.com/Safety for Important Safety Information.
Indications for Use for the da Vinci® Xi™ Surgical System
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Indications for Use for Firefly™ Fluorescence Imaging for the da Vinci Xi Surgical System
The da Vinci® Firefly™ Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Firefly Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct, or common hepatic duct) using near infrared imaging.
Fluorescence imaging of biliary ducts with the da Vinci Firefly Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
Indications for Use for EndoWrist®Stapler 45 for the da Vinci Xi Surgical System
The EndoWrist®Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System for resection, transection and/or creation of anastomoses in general, thoracic, gynecologic and urologic surgery. The device can be used with staple line or tissue buttressing materials (natural or synthetic). The Stapler 45 System and Stapler 45 Reloads should not be used on tissue such as the liver or spleen, where tissue compressibility is such that clamping of the instrument would be destructive. Do not use the Stapler 45 System or Stapler 45 Reloads on the aorta.
Indications for Use for EndoWrist® One™ Vessel Sealer (EndoWrist Vessel Sealer) for the da Vinci Xi Surgical System
The EndoWrist® Vessel Sealer is a bipolar electrosurgical instrument intended for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. The EndoWristVessel Sealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures. The Vessel Sealer is intended for use only with the da Vinci-configured ERBE VIO dV generator. Use of the Vessel Sealer with other generators could result in injury to the patient or surgical team, or cause damage to the instrument.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding regulatory clearances to market the da Vinci Xi System around the world. These forward-looking statements are necessarily estimates reflecting the best judgment of our management and involve a number of risks and uncertainties that could cause actual results to differ materially from those suggested by the forward-looking statements. These forward-looking statements should, therefore, be considered in light of various important factors, including those under the heading "Risk Factors" in our annual report on Form 10-K for the year ended