The Food and Drug Administration (FDA) today cleared the marketing of a robotic-like system to assist in coronary artery by-pass surgery in which there is direct access to the chest using standard open chest technique (sternotomy) or a smaller surgical incision (thoracotomy).
From U.S. FDA:
FDA Clears Robotic-Like Device for Heart Surgery
The Food and Drug Administration (FDA) today cleared the marketing of a robotic-like system to assist in coronary artery by-pass surgery in which there is direct access to the chest using standard open chest technique (sternotomy) or a smaller surgical incision (thoracotomy).
The device enables a surgeon to perform heart surgery while seated at a console with a computer and video monitor.
The surgeon uses handgrips and foot pedals on the 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 general laparoscopic gall bladder and reflux disease surgery (including, for example, gall bladder surgery and reflux disease surgery), and for general non-cardiac thoracoscopic chest surgery, and for thoracoscopically-assisted cardiotomy procedures (including, for example, mitral valve repair).
”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,” said Dr. Lester Crawford, FDA Acting Commissioner.
FDA’s clearance of the system for this new use was based on its review of clinical studies of safety and effectiveness conducted by the manufacturer data submitted by the manufacturer for endoscopic coronary artery by-pass surgery as well as data for other surgical procedures.
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