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Back To Vidyya That's Not A Surgeon, It's A Robot

Robotic Surgical System Receives FDA Approval

Intuitive Surgical, Inc., announced that it received clearance from the U.S. Food and Drug Administration (FDA) to begin commercialization of its da Vinci Surgical System in the United States for use in laparoscopic surgical procedures. Intuitive's da Vinci Surgical System is the only FDA-cleared, complete robotic surgical system commercially available in the United States. This clearance significantly broadens the versatility of Intuitive's technology for potential use in over 3.5 million procedures in the United States. Additionally, the adoption rate of laparoscopic procedures in the United States may increase due to the ease with which surgeons can perform meticulous dissection and suturing using the new technology.

Since the da Vinci Surgical System is now FDA-cleared, hospitals currently using Intuitive's technology can immediately use it for all surgical procedures classified as "laparoscopic," thereby enhancing the viability of their investment. Other complete medical robotic systems currently available in the U.S. can only be used in surgical procedures through a restrictive Investigational Device Exemption (IDE) study approved by the FDA. These IDE studies classify the non-FDA cleared technologies as "experimental."

Safety and effectiveness of the da Vinci Surgical System was confirmed in a controlled clinical trial that compared its use in 228 patients to conventional laparoscopic techniques for removing the gall bladder (Cholecystectomy) and for surgically correcting gastroesophogeal reflux, or heartburn (Nissen Fundoplication). In addition, the FDA determined that a potential change in regulatory path for Intuitive's products might be in order enabling the company to place products on the market faster.

The da Vinci Surgical System consists of a surgeon's viewing and control console having an integrated, high-performance 3-D vision system, a patient-side cart consisting of three robotic arms that position and precisely maneuver endoscopic instruments and an endoscope, and a variety of articulating 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.

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Editor: Susan K. Boyer, RN
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