WASHINGTON — The Food and Drug Administration on Tuesday approved the first robotic medical device that performs surgery.
The technology, surgeons say, eventually could transform highly invasive operations, such as open-chest heart surgery, by enabling doctors to use only small incisions.
With approval of the Da Vinci Surgical System, the surgeon's hand for the first time will be extended far beyond the human touch--another technological leap in an era that already has seen the stuff of science fiction--such as transplants, cloning and test tube babies--become routine.
Guided by a surgeon who sits in front of a console with a computer and video monitor, the system performs laparoscopic surgery, such as gallbladder and other abdominal operations.
The surgeon uses hand grips and foot pedals on the console to control three robotic arms that perform the surgery, using a range of different surgical instruments.
"This system has the potential of converting the majority of our operations into those that are minimally invasive," said Dr. Richard Satava Jr., professor of surgery at the Yale University School of Medicine. "It's fantastic."
In a statement, FDA Commissioner Jane E. Henney called the approval "the first step in the development of new robotic technology that eventually could change the practice of surgery."
While the agency in recent years has licensed other robotic medical devices that assist surgeons--either by positioning instruments and cameras or by inserting needles for biopsy--this is the first one that, in effect, replaces the surgeon's hands in doing the cutting. Others exist, but they are still under study.
The device, made by Intuitive Surgical Inc. of Mountain View, Calif., will at first be used only in general laparoscopic surgery--typically abdominal procedures. In those procedures, a small incision is made in the abdominal wall and an instrument, called a laparoscope, is placed inside that allows surgeons to see structures within the abdomen and pelvis.
Tubes, probes and surgical instruments can be introduced through the same opening, and the surgeon operates while looking through the laparoscope. Laparoscopy eliminates the need for a major incision, thus recovery is typically much faster than it is from conventional surgery.
The new device takes this procedure one major step further by actually doing the cutting and other surgical steps.
