Oct. 16 (UPI) -- The FDA announced recently it has cleared a new robotically-assisted surgical device, the Senhance System, for gynecological and colorectal procedures in adult patients.
RASD allows a surgeon to use computer and software technology to control and move surgical instruments through small incisions in the body. The FDA approved the Senhance System, which is said to offer improved imaging and better controls for doctors, for use in minimally invasive surgical procedures.
The Senhance System is intended to assist the control of laparoscopic instruments for visualization and manipulation of tissue including grasping, cutting, blunt and sharp dissection, ligation, approximation, electrocautery, suturing, mobilization and retraction in laparoscopic colorectal surgery and laparoscopic gynecological surgery.
"Surgeons are approaching the boundaries of minimally invasive care performed with handheld manual instruments and cameras, and are seeking new technologies that will allow us to advance beyond these boundaries," Dr. Steve Eubanks, a general surgeon and executive director of academic surgery at Florida Hospital, said in a press release. "The future will be driven by the appropriate use of robotics and information tools in the operating room. The Senhance platform grants laparoscopic surgeons robotic precision, control of our vision, and haptic feedback while minimizing procedural costs, and is a welcome revolution in our field."
The Senhance System allows surgeons to sit at a console unit or cockpit that gives a 3D high-definition view of the surgical field, allowing them to control three separate robotic arms remotely. Each arm is equipped with surgical instruments based on traditional laparoscopic instrument designs.
The system is unique in that it includes technological characteristics of force feedback to allow the surgeon to feel the stiffness of the tissue being grasped by the robotic arm, eye-tracking to help control movement of surgical instruments and laparoscopic-type controls similar to traditional surgical equipment.
The FDA approved the Senhance System after a clinical trial of 150 patients who underwent various gynecological operations using the system showed clinical outcomes comparable to more than 8,000 gynecological operations performed in real-world settings using other devices.
"Minimally invasive surgery helps reduce pain, scarring and recovery time after surgery," Dr. Binita Ashar, director of the Division of Surgical Devices in the FDA's Center for Devices and Radiological Health, said in a press release. "RASD technology is a specialized innovation in minimally invasive surgery designed to enhance the surgeon's access and visualization within confined operative sites."
