Intuitive Surgical (NSDQ:ISRG) said today that it won 510(k) clearance from the FDA for a new indication for its da Vinci SP robot-assisted surgery device and revealed plans to pursue other indications for the single-port device.
Initially cleared in April 2014 for urological procedures, the da Vinci SP’s newest indication is for procedures requiring very narrow access from a single small incision. Sunnyvale, Calif.-based Intuitive said it plans to ask the FDA to clear transoral, transanal, and extraperitoneal applications for the SP device.
“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,” CEO Gary Guthart said in prepared remarks. “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.”
“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,” added COO Salvatore Brogna.