FDA OKs First Robotic Surgical Device

N E W   Y O R K, July 13 -- The first federally approved surgery to be performed by robots — with the help of human doctors — was performed at a Virginia Hospital Wednesday, one day after federal regulators OK’d the procedure.

The Food and Drug Administration Tuesday approved the first robotic surgery device that enables surgeons to remove gall bladders and perform some other procedures using a laparoscope, a tube that is inserted inside the abdomen through small incisions. At the end of the tube are surgical instruments and miniature cameras that allow surgeons to peer into the body and perform procedures.

With FDA approval of Da Vinci Surgical Systems, a surgeon now is able to use hand grips and foot pedals on a console to control three robotic arms that can actually do the laparoscopic surgery using a variety of tools.

Dr. William E. Kelley Jr. performed the gall bladder removal surgery on35-year-old Kimberly Briggs at Henrico Doctors Hospital in Richmond, Va.

“I was very pleased. I think it went very smoothly,” says Kelley, who hadbeen trained on the Da Vinci but had used it to operate only on pigs andcadavers before. Also pleased was Briggs, who was wheeled into a news conference less thanfour hours after her surgery was over.

“I feel great,” she said, adding that the less invasive procedure wouldallow her to be home in time for her son Mario's sixth birthday party today.

First Robotic Surgical Device OK’d

“The system is the first step in the development of new robotic technology that eventually can change the practice of surgery,” said FDA commissioner Dr. Jane E. Henney when the approval was announced.

The robotic arms, which have a wrist built near the end of the tool, give surgeons the ability to perform more intricate motions.

FDA clearance was based on a review of clinical studies submitted by the manufacturer, Intuitive Surgical, Inc., in Mountain View, Calif.

Intuitive Surgical studied the use of the robotic system on 113 patients who underwent surgery for gall bladder disease or gastroesophageal reflux, or severe heartburn, then compared the results to that of 132 patients who received standard laparoscopic surgery. Results showed the robotic system was comparable to standard laparoscopic surgery in safety and effectiveness, according to the FDA.