FDA OKs First Robotic Surgical Device

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 on 35-year-old Kimberly Briggs at Henrico Doctors Hospital in Richmond, Va.

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

“I feel great,” she said, adding that the less invasive procedure would allow 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.

Learning Curve

While a laparoscopic procedure with the robotic device took 40 to 50 minutes longer, the company attributed it to the doctors’ lack of experience with the new technology.

The company will be developing a training program with the owners of the $1 million system to help them become better acquainted with it, the FDA says.

In 1997, the FDA approved a robotic device to handle a camera in response to a surgeon’s voice, says Sharon Snider, FDA spokeswoman. But the device did not have any surgical tools.

Intuitive spokeswoman Sheila Shah says her firm will be seeking approval to use the robotic technology for cardiac procedures, including some types of bypass and valve replacements and repair. The robotic technology currently is in use in Europe for cardiac surgeries and prostate removals.

Dr. Barry Gardiner, principal investigator on the FDA approval study and director of minimally invasive surgery at San Ramon Regional Medical Center, in San Ramon, Calif., says the system is “expected to advance minimally invasive techniques.”

Dr. Robert Michler, professor and chief of cardiothoracic surgery at Ohio State University, in Columbus, says the technology is designed to be used to “invade the body less traumatically.” Michler, who just completed a clinical study to test the Da Vinci system in heart surgery, says “less trauma means less inflammation and faster recovery, which means patients can return to work and families.”

“For general surgery, we will see very rapid growth for this application,” Michler predicts.

ABCNEWS’ Maria Flores and the Associated Press contributed to this report.

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