TransEnterix Inc., a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, has submitted an indications filing to the U.S. Food and Drug Administration to expand General Surgery usage of the Senhance Surgical System.
 
“This submission is an important milestone for the continued application of Senhance in the highest volume and value procedures,” said Anthony Fernando, president and CEO at TransEnterix. “General Surgery is by far the largest procedural area in minimally invasive abdominal surgery, and we are pleased to have submitted significant additional clinical data to expand the procedures for which surgeons can utilize the benefit of Senhance.”
 
The Senhance System is the first and only digital laparoscopic surgical platform designed to maintain laparoscopic MIS standards while providing digital benefits such as haptic feedback, robotic precision, comfortable ergonomics, advanced instrumentation including, 3 mm mini-laparoscopic instruments, eye sensing camera control and reusable standard instruments to help maintain per-procedure costs similar to traditional laparoscopy. The Senhance System is also the first machine-vision system in robotic surgery which is powered by the new intelligent Surgical Unit (ISU) that enables augmented intelligence in surgery.
 
The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization and retraction. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use.