Intuitive Surgical won another indication from the Food and Drug Administration (FDA) for its da Vinci SP robot-assisted surgery device. The Sunnyvale, Calif.-based company said the FDA added single-port radical tonsillectomy and tongue base resection procedures to the mix.
Initially cleared in April 2014 for urological procedures, in June 2018 the federal safety watchdog added a clearance for procedures requiring very narrow access from a single small incision.
“Today’s FDA clearance means surgeons can utilize da Vinci SP robotic-assisted surgery to conduct radical tonsillectomy and tongue base resection transorally,” CEO Gary Guthart said in prepared remarks. “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,” Guthart said.
It’s been a solid few months for Intuitive Surgical. In February, the FDA cleared Intuitive’s Ion system, which is designed to enable doctors to conduct minimally-invasive biopsies deep within the lung. Ion includes an articulating robotic catheter with an outer diameter of only 3.5 mm that is able to move 180 degrees in all directions, allowing a physician to navigate the catheter through small and tortuous airways to reach nodules.
Intuitive Surgical also in February raised $2 billion via stock repurchases. And in late January, Intuitive Surgical stated that its 2018 fourth-quarter revenue grew 17 percent, to $1 billion. While that was less than expected, it is still quite strong. Intuitive Surgical said it shipped 290 da Vinci Surgical Systems, compared with 216 in the fourth quarter of 2017.