July 9, 2004 -- The FDA has cleared the marketing of a robotic-like system to assist in heart bypass surgery.
The device will be used in open heart bypass surgery in which there is direct access to the chest through an open incision to the chest. The device enables a surgeon to perform heart bypass surgery while seated at a console with a computer and video monitor. The surgeon's hands are used to control the instrument arms within the patient. They control small surgical instruments to perform the heart surgery.
Doctors use heart bypass surgery to open clogged arteries that supply blood to the heart muscles. During the procedure, the surgeon is able to reroute blood supply around the blocked vessels to help prevent a heart attack or worsening heart function. Several arteries can be bypassed during the same surgery.
With the robotic-like system, the surgeon uses handgrips and foot pedals on a console to control three robotic arms that perform the surgery with a variety of surgical tools. The robotic arms, which have a "wrist" built into the end of the tool, give surgeons additional manipulation ability during surgery, providing easier, more intricate motion and better control of tools.
The product, the Da Vinci Endoscopic Instrument Control System, manufactured by Intuitive Surgical Inc., of Mountain View, Calif., is already cleared for use in other types of surgeries, including laparoscopic gall bladder and acid reflux disease surgery, and for other chest surgeries not involving the heart.
"The development of this system for use in the heart is a step forward in new robotic technology that eventually could change the practice of heart surgery," says Lester Crawford, MD, FDA Acting Commissioner.