The US Food and Drug Administration (FDA) has granted 510(k) clearance to a new robotically assisted surgical device (RASD) for use in laparoscopic colorectal and gynecologic surgery.
The Senhance System (TransEnterix Surgical Inc) provides a 3-dimensional high-definition view of the surgical field and allows surgeons to control three robotic arms remotely. The end of each arm is equipped with surgical instruments that are similar in design to traditional laparoscopic instruments, the FDA explained in a news release.
The system also has unique technological characteristics, the FDA said, including force feedback, which helps the surgeon “feel” the stiffness of tissue being grasped by the robotic arm; eye tracking, which helps control movement of the surgical tools; and laparoscopic-type controls similar to those of traditional surgical equipment.
“The Senhance System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization and retraction in laparoscopic colorectal surgery and laparoscopic gynecological surgery,” the FDA said. The system is indicated for use in adult patients by trained physicians.
The system was tested in 150 patients who underwent various gynecologic operations. Clinical outcomes were compared to those described in eight peer-reviewed research publications involving more than 8000 gynecologic operations performed in real-world settings using another RASD. The FDA also reviewed operative results with the Senhance System submitted by the manufacturer involving 45 patients who underwent colorectal procedures.
According to the FDA, “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.
“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.”
The FDA cleared the Senhance System through its 510(k) review process, in which the agency determines that a new medical device is substantially equivalent to one already on the market.
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