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.
Here is a video of Senhance Surgical Systems.
Senhance Surgical Robotic System - Functional Overview from TransEnterix, Inc on Vimeo.
