FDA OKs First Robot for Surgery

Wednesday, July 12th 2000, 12:00 am

By: News On 6

WASHINGTON (AP) â€” The nation's first robotic surgical device may be headed for an operating room near you: The government has given surgeons the green light to use a three-armed assistant named, perhaps appropriately, ``Da Vinci.''

The Da Vinci Surgical System on Tuesday became the first surgical robot to win Food and Drug Administration approval, to help surgeons more easily perform certain operations through tiny cuts in the abdomen, known as laparoscopic surgery.

But consider that a first-generation use. The robot already is being tested on trickier surgeries, including heart bypasses and heart valve replacements performed through three incisions each about the diameter of a pencil.

And FDA experts say the robot's ability to perform precise movements in tiny spaces â€” without trembling like a tired surgeon might â€” could one day allow better microsurgery, such as for nerve-related operations.

``This system is the first step in the development of new robotic technology that eventually could change the practice of surgery,'' said FDA Commissioner Jane Henney.

Regardless of future uses, the Da Vinci robot is a ``powerful'' tool because it can give surgeons more control during today's minimally invasive operations, said Dr. Barry Gardiner of the San Ramon Regional Medical Center, who led clinical trials of the robot.

``When you sit down and operate with this system, it almost feels like you've climbed inside the space you're operating in,'' Gardiner said.

Da Vinci, a $1 million device manufactured by Intuitive Surgical Inc., was tested on laparoscopic gallbladder removals and heartburn-relief operations.

Today, surgeons do those procedures minimally invasively by sliding a tiny video camera inside the patient's body and operating with foot-long scalpels and other instruments stuck into two small incisions. It looks like they're handling long, steel chopsticks while looking up at a fuzzy videoscreen instead of down at the patient.

Laparoscopic surgery is immensely popular and surgeons can do it well, but they complain the instruments are clumsy at best and prevent fine stitches and other micro-techniques.

Da Vinci's camera uses multiple lenses to provide a three-dimensional image from inside the patient's body. The robotic arms replace those foot-long scalpels, and have a ``wrist'' built in for more humanlike flexibility. The arms hold specially designed surgical instruments that mimic movement of the surgeon's hands as he or she operates the robot's joysticks from a computer next to the operating table.

``The computer controls the instruments as if your fingers are grasping the very tip,'' a sensation doctors usually get only in open surgery, Gardiner explained. ``It's a very powerful sensation.''

In a study of 113 patients who underwent robotic gallbladder or heartburn surgery, they did just as well as 132 patients who got standard laparoscopic surgery, said Neil Ogden, the FDA engineer who oversaw Da Vinci's approval.

But the robotic operations took up to 50 minutes longer, in part because surgeons weren't accustomed to the new technology, Ogden said, who warned that the doctors had a learning curve spotted over their first 20 patients.

Already doctors are hunting new uses for Da Vinci. A colleague at Gardiner's hospital is considering fertility surgery that now can't be done minimally invasively. Colon and prostate surgeries that now require fine suturing might become less invasive, too, he said.

Doctors must be specially trained by the Mountain View, Calif., manufacturer to use the robot, the FDA stressed.

Five hospitals are trained to use the Da Vinci now: Henrico Doctors Hospital in Richmond, Va., Baylor Medical Center in Houston; Ohio State University in Columbus; East Carolina University in Greenville, N.C.; and Gardiner's San Ramon Medical Center.

A few other hospitals are conducting clinical trials of robot-assisted heart surgery.

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