While gripping hand controls, depressing foot pedals, and watching a 3-D video display, a surgeon removed the gallbladder of a 35-year-old woman at Henrico Doctor's Hospital in Richmond, Va. The surgery occurred this summer, just one day after FDA cleared for marketing a robotic device to perform laparoscopic gallbladder and gastroesophageal reflux disease (severe heartburn) surgery.

In standard laparoscopic surgery, the surgeon, while standing over the patient, makes up to four small incisions in the abdomen through which tubes are inserted. A miniature camera at the end of one tube enables the surgeon to see into the body and guide instruments through the other tubes to perform minor surgery.

With the robotic device, called the da Vinci Surgical System, the surgeon performs the operation while sitting nearby at a console, viewing a motionless image of the patient and operative site on a video monitor. The image is magnified up to 20 times.

From the console, the surgeon controls three robotic arms holding surgical tools above the operating table. The robotic technology translates the surgeon's movements into precise, real-time movements of the surgical instruments inside the patient. A built-in "wrist" at the end of the tools helps the surgeon to perform more exact and intricate motions without the natural tremors that accompany a surgeon's own hands.

In clinical studies, results of 113 surgeries for gallbladder or gastroesophageal reflux disease using the robotic device were found comparable in safety and effectiveness to the results in 132 patients who underwent standard laparoscopic surgery. However, the robotic surgery took 40 to 50 minutes longer than the standard surgery, which was attributed in part to the lack of experience with the new technology. FDA is working with the manufacturer to develop a training program for surgeons on the device.

Up until now, surgical robots were approved for experimental surgery only. The da Vinci Surgical System, made by Intuitive Surgical, Inc., of Mountain View, Calif., is the first device to be approved for commercial marketing.

"This system is the first step in the development of new robotic technology that eventually could change the practice of surgery," says FDA Commissioner Jane E. Henney, M.D.

Changes in heart surgery are already on the horizon. Robotic devices have been used experimentally to perform heart bypass surgery and heart valve repair and replacement. In April, surgeons at the New York University Medical Center performed the first minimally invasive robotic heart valve surgery in the United States. This successful mitral valve repair on a 50-year-old male was part of an FDA-approved clinical study.

Surgeons currently perform most heart surgery by making a large incision in the chest and cracking open the rib cage. According to Neil Ogden, chief of the General Surgery Devices Branch in FDA's Center for Devices and Radiological Health, "robotics has the potential to allow minimally invasive heart surgery with the chest completely closed."

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FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.