資料來源：https://www.fiercebiotech.com/medtech/transenterix-soars-after-fda-clears-robot-surgical-device

TransEnterix Surgical has received FDA clearance to sell its robotically assisted surgical device, sparking a 75% jump in its stock price. The green light marks the arrival of a rare new entrant to the field of abdominal surgery robotics.

Research Triangle Park, North Carolina-based TransEnterix has designed its device, the Senhance System, to make it easier for doctors to perform laparoscopic surgery. The surgeon sits at a console equipped with a monitor showing the operating area and moves three robotic arms using a joystick. Haptic feedback is provided so the surgeon can gauge the stiffness of tissue grasped by the robotic arms. Eye-sensing technology controls the camera.

Collectively, the features are designed to enable surgeons to see and accurately grasp, cut, suture and otherwise manipulate tissues from a more comfortable position. TransEnterix thinks this sets the Senhance System up to fill a gap in the market.  

“Millions of surgical procedures in the U.S. are performed each year laparoscopically with basic manual tools that limit surgeons’ capability, comfort and control,” TransEnterix CEO Todd Pope said in a statement. “New choices are needed that enhance the senses, control and comfort of the surgeon, minimize the invasiveness of surgery for the patient and maximize value for the hospital.”

TransEnterix picked up the 510(k) clearance on the strength of results from a 150-patient clinical trial. Investigators used the Senhance System to perform a range of gynecological procedures and compared the outcomes to historical results achieved by older robotically assisted devices. 

The FDA also reviewed results from 45 patients who underwent colorectal procedures, real-world evidence and tests performed under simulated worst-case conditions before ruling that the device is substantially equivalent to Intuitive Surgical’s da Vinci Si in colorectal and gynecological surgeries.

TransEnterix will now take this data to surgeons and healthcare systems in an attempt to get them to adopt its technology over those sold by the incumbent, Intuitive Surgical. The availability of a technology from a new company is a novel experience for these buyers. TransEnterix thinks it is the first new entrant to the abdominal surgical robotics sector since 2000.