FDA approves Senhance Surgical Robotic System to facilitate minimally invasive surgery

FDA today approved Senhance Systems, by TransEnterix, Inc., a medical device company that is pioneering the use of robotics to improve minimally invasive surgery.

Robotically-assisted surgical device (RASD) is a type of computer assisted surgical system, which helps surgeon to control, view and move the surgical devices through small ports of minimal invasive surgery in a variety of surgical procedures. It specifically has gynecological and colorectal applications.

The system enables the surgeon to sit in a console or a cockpit of some sort, 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. At the end of each of the 3 arms are mounted surgical instruments that are based on traditional laparoscopic instrument designs. This increases the surgeon’s comfort and reduces strain.

The 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 facilitates highly efficient operations with minimal additional docking time or change to technique.

 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. 

“Minimally invasive surgery helps reduce pain, scarring and recovery time after surgery,” said Binita Ashar, M.D., 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.” 

The clearance was based on results of a pilot study in which 150 patients underwent various gynecological operations with the Senhance System. The clinical outcomes were compared with outcomes of nearly 8000 surgeries in real world settings using another RASD.

In addition to gynecological surgeries, 45 colorectal sureries were also performed by Senhance system and compared to outcomes of other real-world surgeries.

Based on the study results, real world evidence and simulations, the FDA concluded that the  Senhance System is substantially equivalent to the da Vinci Si IS3000 device for gynecological and colorectal procedures.

Here is a  video of Senhance Surgical Systems. 


Senhance Surgical Robotic System - Functional Overview from TransEnterix, Inc on Vimeo.