The Food and Drug Administration has approved a new robotically assisted surgical device that can help facilitate minimally invasive surgery, enabling surgeons to use computer and software technology to control and move surgical instruments through one or more tiny incisions in a patient’s body.
The Senhance Surgical Robotic System from TransEnterix, which was reviewed by the FDA through the 510(k) premarket clearance process, was cleared primarily based on a clinical study of 150 patients undergoing various gynecological operations with the robotically assisted surgical device (RASD).
“Clinical outcomes were compared to those described in eight peer-reviewed research publications involving more than 8,000 gynecological operations performed in real-world settings (real-world evidence) using another RASD,” states the regulatory agency’s announcement. “In addition, the manufacturer submitted Senhance System operative results involving 45 patients undergoing colorectal procedures in a real-world setting and compared the results to those from peer-reviewed research publications describing the real-world device experience.”
As a result, the FDA concluded that these study data—supported by real-world evidence, along with performance testing under simulated use and worst-case scenario conditions—demonstrated the “substantial equivalence of the Senhance System to the da Vinci Si IS3000 device for gynecological and colorectal procedures.”
“The clearance of the Senhance System in the U.S. is a milestone in the progress of robotics and is expected to deliver improvement in the efficacy, value and choices offered to patients, surgeons and hospitals,” said Todd Pope, president and CEO of TransEnterix. “Millions of surgical procedures in the U.S. are performed each year laparoscopically with basic manual tools that limit surgeons' capability, comfort and control. 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. Senhance is this new choice.”
Using the system, a surgeon sits at a console that provides a 3-D high-definition view of the surgical field and allows them to direct three separate robotic arms remotely. According to the manufacturer, technology such as haptic feedback and eye sensing camera control—included for the first time in a robotic surgery platform—help the surgeon “feel” the stiffness of tissue being grasped by the robotic arm and to control movement of the surgical tools and laparoscopic instruments.
“Minimally invasive surgery helps reduce pain, scarring and recovery time after surgery,” said Binita Ashar, MD, 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.”
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