New Robotically Assisted Surgical Device Receives FDA Approval
TransEnterix Surgical, Inc has received 510(k) clearance from the US Food and Drug Administration (FDA) for its new robotically assisted surgical device (RASD) , the Senhance System, for use in laparoscopic colorectal and gynecological 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.
This system is the latest in attempts to further reduce pain and risks associated with more invasive procedures while providing hi-tech features that allow for optimum human control over instruments:
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.
Physicians using this technology will get a boost in accuracy and efficiency while performing standard laparoscopic procedures.
"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.