FDA Approves New Robotic Surgery Device

The U.S. Food and Drug Administration has cleared for marketing a robotic device that enables a surgeon to perform laparoscopic gall bladder and reflux disease surgery while seated at a console with a computer and video monitor.
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The surgeon uses hand grips and foot pedals on the console to control three robotic arms that perform the surgery using a variety of surgical tools.

The product, the Da Vinci Surgical System, made by Intuitive Surgical, Inc., of Mountain View, Calif., is the first of its kind.

"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 E. Henney, M.D.

The robotic arms, which have a "wrist" built in to the end of the tool, give surgeons additional manipulation ability during laparoscopic surgery, enabling easier, more intricate motion and better control of surgical tools.

In standard laparoscopic surgery, surgeons pass a laparoscope, a flexible fiberoptic instrument equipped with biopsy forceps, scissors and other surgical tools, through a small incision in the abdominal wall to view the abdominal cavity and perform minor surgery.

The new robotic system is intended to be used in an operating room in laparoscopic procedures, for example for gall bladder disease or gastro-ensophageal reflux disease (severe heartburn).

FDA clearance was based on a review of clinical studies of safety and effectiveness submitted by the manufacturer and on the recommendation of the General and Plastic Surgical Devices Panel of FDA's Medical Devices Advisory Committee.

Intuitive Surgical studied use of the robotic system on 113 patients who underwent surgery for gall bladder or reflux disease, then compared them to 132 patients who received standard laparoscopic surgery.

Results showed that the robotic system was comparable to standard laparoscopic surgery in safety and effectiveness. While the surgical procedures with the robotic device took 40 to 50 minutes longer than standard laparoscopic surgery, this was attributed, in part, to lack of surgical experience with the new technology.

Because of the expected learning curve with the new system, Intuitive Surgical is developing a training program for surgeons in collaboration with FDA.