The FDA has approved a robotic device that mimics surgeons' hand movements to perform operations such as open-heart surgery.
Although the da Vinci system is the only one of its kind approved by the FDA, the company already faces patent infringement accusations from rival medical robotics company Computer Motion.
The da Vinci system, designed by Intuitive Surgical, combines robotics and computer imaging. It allows doctors to perform heart surgery by controlling miniature hands inside the chest cavity through one-centimeter incisions. Surgeons control the robotic appendages with joysticks and watch their progress via a 3-D computer image.
The $1 million system uses two pencil-sized arms that enter the chest, which doctors say allows them to immerse themselves in the topography of the heart. The da Vinci system is FDA approved for all laparoscopic procedures.
"It gives you seven degrees of freedom (of movement) at the wrist, just like the human wrist, and it's got wonderful ergonomics," said Randolph Chitwood, chairman of the department of surgery at the East Carolina University School of Medicine in Greenville, North Carolina.
The da Vinci system has already been put into action. The Henrico Doctors' Hospital in Richmond, Virginia, on Wednesday became the first US hospital to perform general surgery using the surgical system.
"Complex operations that are now done through large incisions, and some operations that we can't even envision today, will become routine through tiny incisions with this system in the years ahead," said Dr. William E. Kelley Jr., the operating surgeon, in a statement.
The FDA said the robotic arms give surgeons better control of surgical tools. Researchers tested the system on 113 patients and compared their success to 132 patients who had standard surgery. The tests showed the robotic system produced similar safety and effectiveness, the FDA said.
Surgery with the robotic system took 40 to 50 minutes longer, but the FDA attributed that in part to surgeons' lack of experience with the new technology.
Surgeons have used the da Vinci system to perform over 600 operations in other countries, mostly in Europe.
Intuitive's da Vinci system is similar to the Intelligent Operating Room, under development by Computer Motion.
Computer Motion holds patents on eight robotic surgical systems, and claims Intuitive has infringed on all of them in the da Vinci as well as in other products. The company recently filed a patent infringement lawsuit in the US District Court for the Central District of California in Los Angeles.
Computer Motion's technology can be used only under an Investigational Device Exemption from the FDA for experimental procedures. The company expects to begin patient enrollment for clinical trials during the third quarter.
Still, patent attorneys believe that Intuitive may be forced either to pay a licensing fee to Computer Motion or to redesign the da Vinci system.
"This may be painful and it may cost a lot of money, but it all typically works out in the end with a settlement," said John Lynch, a patent attorney with the Howrey, Simon, Arnold, and White in Menlo Park, California.
The FDA said it will review Computer Motion's Zeus Robotic Surgical System using a shorter 90-day approval process instead of the normal 180-day process.
Reuters contributed to this report.
