Intuitive Surgical Inc. received FDA approval for the da Vinci Xi Surgical System with Table Motion in January 2016.
The da Vinci Xi Surgical System with Table Motion, is the company’s fourth generation, robotic-assisted surgical platform available for use in the United States.
The core technology included in all da Vinci platforms includes a surgeon’s console, a patient-side cart, a vision system, and proprietary instruments. The da Vinci Xi Surgical System added features include: modification to the overhead architecture/patient-side cart with a boom mount so that multi-quadrant surgery can be performed without extensive repositioning, a laser targeting system to improve the ease of robotic arm set up, thinner arms/instruments with longer reach, and a movable endoscope which can be positioned on any of the four robotic arms. The da Vinci Xi also includes improved 3D HD vision, integrated “Firefly” fluorescence imaging, and an integrated energy source (monopolar/bipolar/tissue sealing).
Integrated Table Motion combines da Vinci® Xi™ Surgical System and Trumpf Medical’s TruSystem® 7000dV OR Table so that a patient can be dynamically positioned while the surgeon operates. Integrated Table Motion allows the surgical team to reposition the patient by adjusting the operating table without undocking from the Xi surgical system.
The FDA determined the da Vinci Xi Surgical System is equivalent to predicate devices.
FDA approved indications for use:
- General Laparoscopic Surgical Procedures
- Laparoscopic Urologic Surgical procedures
- Laparoscopic Gynecologic Surgical Procedures
SAGES Technology & Value Assessment Committee
Tech Alert, June 2016
By Nova Szoka, MD