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.
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"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.
For more information visit Transenterix.com.