Dive Brief:
- Intuitive Surgical said Wednesday its da Vinci SP surgical robot received Food and Drug Administration clearance for use in inguinal hernia repair, gallbladder removal and appendectomy procedures.
- The clearances add to the single port robot’s indications in urology, colorectal, thoracic and transoral procedures, as Intuitive works to expand adoption of the platform, launched in the U.S. in 2018.
- The SP system, for surgery through a single incision or natural orifice, is designed to help surgeons access narrow or deep spaces within the body to perform more complex procedures. The surgeon can control up to three multi-jointed instruments and a 3D-HD imaging endoscope through the entry point.
Dive Insight:
Compared with Intuitive’s multiport da Vinci robot, the single port version represents a small portion of the company’s overall system base. Of the more than 1,790 systems the robot maker placed last year, about 95 were single port. More than 290 da Vinci SPs were installed in hospitals globally at the end of 2024, compared with more than 9,890 da Vinci multiport systems.
Procedures performed with the da Vinci SP rose 91% in the third quarter, according to Intuitive, and management expects new indications to increase use of the system.
CEO Dave Rosa, on the company’s third-quarter call, said international markets, especially Korea, and early U.S. use of the recently introduced single port stapler in colorectal and thoracic surgeries drove procedure growth with the single port robot in the period.
Intuitive received FDA clearance for the single port stapler in April. Last year, the FDA cleared da Vinci SP for use in general thoracoscopic surgical procedures and colorectal surgeries.
The company has also made regulatory submissions for the system for nipple-sparing mastectomy and other general surgery procedures, Rosa said.
Other companies developing single port robotic surgery systems include Virtual Incision and Vicarious Surgical.
