Robotic system that helps with minimally invasive surgery gains FDA approval

A new robotically-assisted surgical device (RASD) that can help with minimally invasive surgery has been cleared by the FDA.

The Senhance System, developed by TransEnterix Surgical, allows surgeons to control three separate robotic arms remotely from a console that provides a 3D high-definition view of the surgery. Each arm is equipped with a surgical instrument based on traditional laparoscopic instrument designs. The system includes other features such as force feedback and eye-tracking, which helps the surgeon feel the firmness of grasped tissue and helps to control the movement of the arms.

RASD is used to benefit minimally invasive surgery and assist with complex tasks in confined areas of the body.

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

TransEnterix Surgical conducted a clinical study of 150 patients undergoing various gynaecological operations with the Senhance System. Clinical outcomes were compared to those described in different publications that featured over 8,000 gynaecological operations using another RASD. TransEnterix Surgical also submitted 45 operative results on patients using the Senhance System.

The system was reviewed through the pre-market clearance (510K) pathway, which demonstrates that the device is equivalent to a previous legally marketed device.