Robotically-Assisted Device Cleared for Surgery Use
The Food and Drug Administration (FDA) has cleared a new robotically-assisted surgical device (RASD), the ‘Senhance System' (TransEnterix Surgical Inc.), indicated for minimally invasive surgery in adults. The system gained approval through the 510(k) premarket clearance pathway.
The Senhance System is controlled by a surgeon at a console unit which provides 3D, high-definition views of the surgical field. Three robotic arms equipped with surgical instruments can then be moved remotely; the instruments are based on traditional laparoscopic instruments.
“RASD technology is a specialized innovation in minimally invasive surgery designed to enhance the surgeon's access and visualization within confined operative sites,” said Binita Ashar, MD, direct of the Division of Surgical Devices at the FDA.
The device is intended to enhance the accuracy 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.
A clinical study of the device assessed the outcomes of 150 patients undergoing various gynecological operations compared to 8 peer-reviewed published studies that included ≥8,000 operations performed using other RASDs. The FDA concluded that the 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.”
For more information visit Transenterix.com.