FDA clears Intuitive Surgical's robotic-like device for cardiac revascularization

Sunnyvale 08 July 2004The Food and Drug Administration (FDA) has 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 or sternotomy or a smaller surgical incision, called thoracotomy. The device enables a surgeon to perform heart surgery while seated at a console with a computer and video monitor.

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The FDA clearance has been granted for use of the da Vinci Surgical System to perform coronary anastomosis during cardiac revascularization. This clearance follows the submission of data from a multi-centre clinical trial involving use of the da Vinci Surgical System to perform internal mammary artery anastomosis to the left anterior descending coronary artery. This indication broadens the use of the da Vinci Surgical System, allowing surgeons in the United States to perform coronary artery bypass surgery with small incisions.

The product, the Da Vinci Endoscopic Instrument Control System, manufactured by Intuitive Surgical Inc., of Mountain View, California, 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", stated Dr. Lester Crawford, FDA Acting Commissioner.

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.

Commenting on the clearance, Lonnie Smith President and CEO of Intuitive Surgical, stated: "We are pleased with the FDA's most recent cardiac clearance for the da Vinci Surgical System which adds cardiac revascularization to the intra-cardiac procedures previously cleared by the agency. United States surgeons can now use the da Vinci Surgical System to perform minimally invasive cardiac revascularization offering their patients an attractive alternative to traditional cardiac surgery.

Michael Argenziano, M.D., Assistant Professor of Surgery at the Columbia University College of Physicians and Surgeons, and Director of Minimally Invasive Cardiac Surgery and Arrhythmia Surgery at New York-Presbyterian Hospital, principal investigator for the study, stated: "With the current FDA clearance, which is based on data obtained in our multi-centre trial of endoscopic coronary artery bypass grafting, the da Vinci Surgical System is now available to facilitate a broad range of minimally invasive cardiac surgery, from intracardiac procedures such as valve repair to epicardial procedures such as cardiac revascularization. I am confident that the da Vinci System will become an important part of every cardiac surgeon's technical arsenal, ultimately improving the way we treat patients suffering from cardiovascular disease."

Douglas Murphy, M.D., Chief of Cardiac Surgery at St. Joseph's Hospital of Atlanta, and an investigator in the trial, stated: "We can now perform robotic cardiac revascularization in its entirety, from internal mammary artery harvest to performing the critical anastomosis with unparalleled precision. This clearance provides better surgical options for our patients while advancing the frontiers of minimally invasive cardiac surgery."

The da Vinci Surgical System consists of a surgeon's viewing and control console having an integrated, high-performance InSite 3D vision system, a patient-side cart consisting of three or four robotic arms that position and precisely manoeuvre endoscopic instruments and an endoscope, and a variety of articulating EndoWrist Instruments. By integrating computer-enhanced technology with surgeons' technical skills, Intuitive believes that its system enables surgeons to perform better surgery in a manner never before experienced. The da Vinci Surgical System seamlessly and directly translates the surgeon's natural hand, wrist and finger movements on instrument controls at the surgeon's console outside the patient's body into corresponding micro-movements of the instrument tips positioned inside the patient through small puncture incisions, or ports.

The Aesop Endoscope Positioner is a voice-activated robotic arm that automates the critical task of endoscope positioning, providing the surgeon with direct control over a smooth, precise and stable view of the internal surgical field. The Hermes Control Center is a centralized system designed to voice control a series of networked "smart" medical devices. More news about the da Vinci surgical system is available in the VMW June 2004 article St. John's Hospital uses da Vinci's robot-assisted surgery to fight deadly cancer


Leslie Versweyveld

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