The U.S. FDA has cleared the Senhance System, a new robotically-assisted surgical device (RASD) that can help facilitate minimally invasive surgery, developed by Morrisville, N.C.-based TransEnterix Surgical Inc.
“Minimally invasive surgery helps reduce pain, scarring, and recovery time after surgery,” says Binita Ashar, MD, director of the division of surgical devices in the FDA’s Center for Devices and Radiological Health. “RASD technology is a specialized innovation in minimally invasive surgery designed to enhance the surgeon’s access and visualization within confined operative sites.”
RASD, or robotic surgery, enables the surgeon to use computer and software technology to control and move surgical instruments through one or more tiny incisions in the patient’s body (laparoscopic surgery) in a variety of surgical procedures or operations. The benefits of RASD technology may include its ability to facilitate minimally invasive surgery and assist with complex tasks in confined areas of the body.
Further, the design of the Senhance System allows surgeons to sit at a console unit or cockpit that provides a 3D high-definition view of the surgical field and allows them to control three separate robotic arms remotely. The end of each arm is equipped with surgical instruments that are based on traditional laparoscopic instrument designs.
The Senhance 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 in laparoscopic colorectal surgery and laparoscopic gynecological surgery. The system is for use on adult patients by trained physicians in an operating room environment.