FDA OKs Robotic Device That Performs Surgery
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.
The robotic arms, which have a “wrist” built into the end of the tool, give surgeons more dexterity and the ability for additional manipulation, “enabling easier, more intricate motion and better control of surgical tools,” the FDA said.
Intuitive studied the system on 113 patients who underwent surgery for gallbladder or reflux disease, then compared them with 132 patients who received standard laparoscopic surgery. The robotic system proved comparable to standard laparoscopic surgery in safety and efficacy, the FDA said.
Dr. Fred Moll, Intuitive’s medical director and co-founder, predicted that the rate of laparoscopic surgeries in the United States will increase “due to the ease with which surgeons can now perform meticulous dissection and suturing” using the device.
The company said the new system will make existing laparoscopy easier and make more difficult laparoscopic procedures “routine.”
Those procedures that are performed “only rarely” using laparoscopic techniques will “be performed routinely and with confidence,” the company said, adding that “we believe [the system] will enable more surgeons at more institutions to perform these procedures.”
In the past, Yale’s Satava said, surgeons have tried to use a laparoscope to perform surgery in the spleen, colon and stomach, but with only minimal success because their dexterity was limited.
Satava said he and others have long regarded laparoscopy as “the transition from doing things wide open to doing things with robots through tiny incisions.
“I believe that a decade from now, a majority of surgery will be done using these systems through laparoscopes,” added Satava, a member of the American College of Surgeons’ committee for emerging surgical technologies and education.
Procedures using the device, however, take longer than standard laparoscopic surgery--as much as 40 to 50 minutes longer. The FDA attributed this, in part, to lack of surgical expertise with the new equipment and said that the company is developing a training program for surgeons.
The devices also are quite expensive--from $750,000 to $1 million each, compared with up to $80,000 for a laparoscopic system, according to Satava. But he believes the device has the potential to eventually save considerable money once it is widely used in other surgical procedures, such as heart surgery, where it would replace very expensive systems.
“If you got rid of the heart bypass machine, you’d get rid of half the cost of the operation,” he said. “Also, prices will be coming down.”
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Doctor From a Distance
FDA experts say the robot has the ability to perform precise movements in tiny spaces--without trembling like a tired surgeon might. The arms hold specially designed surgical instruments that mimic movement of the surgeon’s hands as he or she operates joysticks from a computer next to the operating table.
Source: Intuitive Surgical Inc.
