Intuitive Surgical OKd by FDA on urological surgery system

Intuitive Surgical, Inc. (Nasdaq: ISRG), today announced a new U.S. Food and Drug Administration (FDA) clearance for the da Vinci SP surgical system for urologic surgical procedures that are appropriate for a single port approach.

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 helps surgeons perform more complex procedures. Intuitive anticipates pursuing further regulatory clearances for da Vinci SP, including transoral, transanal, and extraperitoneal applications, broadening the applicability of the SP platform over time.

“The da Vinci SP is the latest in our integrated product family that shows our commitment to improving minimally invasive surgery with technology that can positively impact patient outcomes,” said Gary Guthart, chief executive officer for Intuitive. “Our da Vinci SP compliments da Vinci X^® and Xi^® 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.”

The da Vinci SP system includes three, multi-jointed, wristed instruments and the first da Vinci fully wristed 3D HD camera. The instruments and the camera all emerge through a single cannula and are properly triangulated around the target anatomy 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.

“Intuitive continues to bring tomorrow’s surgery today by addressing surgeon and patient needs, as well as working closely with hospitals to systematically improve the overall experience in the operating room,” said Salvatore J. Brogna, Intuitive executive vice president and chief operating officer.

Since the initial U.S. FDA clearance in April 2014 for the da Vinci SP surgical system, Intuitive invested in important platform refinements. Intuitive plans to launch the da Vinci SP surgical system in the United States in a measured fashion, with customer shipments beginning in the third quarter of 2018.

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