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U.S. FDA clears da Vinci SP for certain transoral otolaryngology procedures

Press releases may be edited for formatting or style | March 19, 2019 Operating Room
SUNNYVALE, Calif., March 15, 2019 (GLOBE NEWSWIRE) -- Intuitive (Nasdaq:ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, today announced it has received clearance for the da Vinci SP® surgical system for use in certain transoral otolaryngology procedures in adults. The FDA cleared the single port approach for lateral oropharyngectomy procedures (commonly referred to as radical tonsillectomy) and tongue base resection.

"Today’s FDA clearance means surgeons can utilize da Vinci SP robotic-assisted surgery to conduct radical tonsillectomy and tongue base resection transorally,” said Gary Guthart, Intuitive CEO. “Our single port innovation is part of our commitment to helping surgeons and their teams improve patient outcomes, decrease variability in surgery, and improve the patient and surgical team experience.”

The da Vinci SP system provides surgeons with robotic-assisted technology designed for deep and narrow access to tissue in the body. The ability to enter the body through a single, small incision or through a natural orifice can provide a minimally invasive experience for complex procedures.

“Intuitive’s da Vinci SP complements our other systems by enabling surgeons to access narrow workspaces while maintaining high quality vision, precision, and control that surgeons have come to trust from da Vinci systems,” said Guthart.

The da Vinci SP system includes three, multi-jointed, wristed instruments and a fully wristed 3D HD camera. The instruments and the camera all emerge through a single cannula and are properly triangulated around the target anatomy at the distal tip to avoid external instrument collisions that can occur in narrow surgical workspaces. The system enables flexible port placement and excellent internal and external range of motion (e.g., 360-degrees of anatomical access) through the single SP arm. Surgeons control the fully articulating instruments and the camera on the da Vinci SP system, which uses the same surgeon console as the da Vinci X® and Xi™ systems.

Transoral otolaryngology procedures represent the second category of procedures the FDA has cleared for the da Vinci SP surgical system; the FDA cleared the da Vinci SP system for urology procedures in May 2018. Since the initial clearance, Intuitive has shipped 15 da Vinci SP systems in 2018. With this additional indication, Intuitive plans to continue with its measured introduction of the da Vinci SP system in 2019.


About Intuitive Surgical, Inc.
Intuitive (Nasdaq: ISRG), headquartered in Sunnyvale, Calif., is a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery. At Intuitive, we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

Intuitive brings more than two decades of leadership in robotic-assisted surgical technology and solutions to its offerings, and develops, manufactures and markets the da Vinci® surgical system and the Ion™ endoluminal system.

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