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FDA clearance will be sought this year.
TransEnterix Inc., a Research Triangle Park, N.C.-based medical device company focusing on flexible instruments and robotics to improve minimally invasive surgery, today announced that multiple surgeons have used Surgibot, the company’s patient-side minimally invasive robotic system, to successfully complete general surgery procedures in the porcine model. The procedures performed in the pre-clinical testing included cholecystectomy (surgical removal of the gall bladder) and sleeve gastrectomy (partical surgical removal of the stomach). Michel Gagner, M.D., who is president of the 2014 World Congress of the International Federation for the Surgery of Obesity & Metabolic Disorders, is among the surgeons participating in the pre-clinical testing. “Surgibot has promise as a patient-side robotic system for precise dissection during many types of surgical procedures,” Gagner said. “As an experienced laparoscopic surgeon, I appreciate the benefits of robotic precision, strength and ergonomics while remaining in control of the operative site in the sterile field. The system also allows the surgeon to control multiple instruments and a camera and therefore reduce reliance on other assistants during procedures.” “We’re pleased to have achieved this important milestone in the development of SurgiBot,” said Todd M. Pope, president and CEO of TransEnterix. “We are committed to executing our plan of delivering a revolutionary patient-side robotic system to benefit patients, surgeons and hospitals.” The company plans to submit a 510(k) application for clearance with the U.S. Food and Drug Administration for the Surgibot system later in 2014. The Surgibot is a minimally invasive robotic surgery system. The system is designed to utilize a small incision—often hidden inside the belly button. Surgibot is touted to provide multiple channels to the surgeon capable of accommodating both rigid and flexible articulating instruments which offer dexterity in complex surgical tasks. The instruments are designed to give the surgeon needed strength and precision in an ergonomically comfortable manner while maintaining tactile feel. Surgibot also integrates high-definition, 3-D visualization to restore the depth perception that’s lost in traditional laparoscopic procedures.
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