Hearts of Gold
Medical regulators in the federal government share the increasing enthusiasm for robotically assisted surgery. In approving the million-dollar da Vinci system made by Intuitive Surgical of Mountain View, Calif., the FDA gave the technology a verbal pat on the chassis. “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. At the same time, the FDA notified Intuitive Surgical’s chief rival, Computer Motion in Goleta, Calif., that robotic surgery devices will be cleared for market release on an accelerated basis. This makes it likely that Computer Motion’s $750,000 ZEUS Robotic Surgical System will also be approved by the FDA for sale for some procedures by sometime next year. (Like all medical devices, robotic surgery equipment must be approved by the FDA separately for each type of procedure.)
When it comes to robot-assisted surgery, however, the performance of cardiac procedures is the Holy Grail. More than 400,000 open-heart surgeries are performed each year in the United States, at a cost of nearly $20 billion. Both lifesaving and expensive (typically $25,000 per operation), open-heart coronary bypass surgery is often referred to as the “gold standard” by practitioners and hospital administrators.
Cardiac surgeons say the looming presence of robotics in the operating room could revolutionize the operations. “The integration of computers and robotics will have as great an impact as the introduction of anesthesiology into the operating room,” said heart surgeon Ralph Damiano Jr., speaking at the recent Fourth International Congress on Computers and Robotics in the Operating Room, in Santa Barbara, Calif. At the same time, Damiano, who in 1998 was the first physician in the United States to perform robotically assisted heart bypass surgery, cautioned that the technology alone is not enough to guarantee wide-scale adoption of the techniques; operating-room economics apply too.
The challenge is to demonstrate that, in addition to reducing operating overhead with fewer personnel in the operating room and shorter patient hospital stays, robotic surgery will also result in improved outcomes over current methods, attracting even more patients. By focusing on heart operations, the manufacturers of the new surgical equipment are banking on this becoming the earliest area of wide adoption-and for good reason. According to Jan Wald, senior vice president for equity research at George K. Baum & Co., “the profit margin for hospitals is very low, only about 2.5 percent-no more than what supermarkets make. But cardiac surgery is very profitable; it’s a big moneymaker in any hospital.” Hence the anticipated market for high-priced, high-tech computer-assisted cardiac surgery systems, which are second in cost only to magnetic resonance imaging and other sophisticated medical imaging systems in today’s big-ticket capital equipment for hospitals.