Intuitive’s da Vinci SP Earns Expanded EU Nod

Intuitive’s da Vinci SP (single-port) surgical robotic system has received CE mark approval for transvaginal gynecological procedures.

This expands daVinci SP’s EU-approved applications, which already include endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, transanal colorectal, and breast surgical procedures.

da Vinci SP allows single-incision or natural-orifice procedures with enhanced visualization and precision in narrow or deep anatomy. From one entry point, surgeons can control three multi-jointed instruments and a fully articulating 3DHD endoscope, accessing complex anatomy while minimizing tissue disruption, Intuitive claims.

The single-port surgical robot is approved in the U.S., Japan, and Korea for a variety of multidisciplinary surgical procedures. In December, it earned U.S. Food and Drug Administration (FDA) nods for inguinal hernia repair, cholecystectomy, and appendectomy procedures.

Comments from Intuitive execs

Dirk Barten, commercial president for Europe: “Building on the strong adoption of da Vinci SP in women’s health, this approval is a meaningful step forward, not just as a regulatory milestone, but because it expands access to less invasive options for women across Europe and opens the door to potentially better recovery experiences and outcomes.”

Tilman Schlick, VP medical affairs and medical officer: “Transvaginal procedures expand the natural orifice surgery portfolio of the da Vinci SP System, which to this day includes successful transoral and transanal procedures. These less invasive, scarless surgery approaches have the potential to shorten recovery times and enhance patients’ experience as they return to their daily lives. As we continue to innovate across our platforms, we remain focused on helping more patients access the benefits of minimally invasive care.”