Authors: Allyne Topaz, MD & Luca Milone, MD
TransEnterix Surgical, Inc. received FDA approval for the Senhance Surgical Robotic System on October 13, 2017.
The Senhance Surgical Robotic System is a new robotically-assisted surgical device (RASD) that can help facilitate minimally invasive surgery. This robotic platform allows surgeons to sit at a console unit with 3D high-definition view and remotely control three separate robotic arms. Additional components include an advanced eye sensing camera control, which allows the surgeon to control the camera with eye movements, requiring forward and backward head movement for zooming motions. The system also includes haptic force feedback which allows the surgeon to “feel” tissue stiffness.
The robotic platform utilizes standard laparoscopic trocars and functions with a set of reusable, non-wristed 5mm laparoscopic instruments. The console is composed of a 3D high-definition monitor, requiring specialized 3D glasses, an eye tracking camera, 2 master laparoscopic controllers, and a control pedal for instrument energy activation.
The FDA has determined this device to be substantially equivalent to predicate device: the da Vinci Si IS3000 device. However, the Senhance differs from the predicate device, as the predicate uses wristed instruments, whereas Senhance instruments are similar to traditional laparoscopic instrumentation. Note that in Europe, the company has been approved for a fourth robotic arm and an articulating needle driver.
The manufacturer conducted two clinical studies, one of 150 patients who underwent various gynecological operations, and one of 45 patients undergoing colorectal procedures. Clinical outcomes from each of these studies was compared to results from peer-reviewed research publications describing outcomes from operations which used the predicate device. The FDA determined that these studies demonstrated the substantial equivalence of the Senhance Surgical Robotic System to the da Vinci Si IS3000 device for gynecological and colorectal procedures.
- The Senhance is FDA approved for use by trained surgeons in the adult population for laparoscopic gynecological and colorectal procedures.
- No specific contraindications are so far listed, however the usual contraindications to laparoscopic and/or robotic surgery apply.