FDA Approves Senhance Robotic System

The US Food and Drug Administration (FDA) gave the nod to the Senhance System, a robotically-assisted surgical device (RASD) for the facilitation of minimally invasive surgery on adult patients.

The FDA’s decision was made on the clinical data from a study of 150 patients undergoing gynecological procedures that utilized the system. The outcomes of these 150 patients were compared to those of 8000 previously conducted real-world operations using another RASD.

The Senhance System, produced by TransEnterix Surgical Inc., allows for a surgeon to sit in a cockpit of sorts during the procedure, which provides him or her with a 3D, high-definition view of the surgical field and allows for the control of the system’s 3 robotic arms.

“Minimally invasive surgery helps reduce pain, scarring and recovery time after surgery,” Binita Ashar, MD, the director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health, said in a statement. “RASD technology is a specialized innovation in minimally invasive surgery designed to enhance the surgeon’s access and visualization within confined operative sites.”

The technology works by moving surgical instruments through 1 or more small incisions, known as laparoscopic surgery, in a multitude of different procedures. Each arm of the Senhance System is equipped with instruments based on the standard designs for laparoscopic surgery tools.

TransEnterix’s system allows the surgeon to “feel” the stiffness of tissue during operation with its force feedback technology. It also features eye-tracking to allow for comparative movement of instruments to standard operations. It allows for the visualization and endoscopic manipulation of human tissue, such as grasping, cutting, blunt and sharp dissections, approximation, ligation, electrocautery, suturing, mobilization and retraction in laparoscopic colorectal surgery and laparoscopic gynecological surgery," according to the FDA