This approval adds to da Vinci SP’s CE-marked existing applications in Europe: endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, transanal colorectal, and breast surgical procedures.
“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,” Dirk Barten, Intuitive commercial president for Europe, said in a news release out yesterday.
Originally launched in 2014, the da Vinci SP system (versus da Vinci multiport systems, the most recent being the da Vinci 5) enables surgeons to perform procedures through a single incision or natural orifices. Through a single-entry point, surgeons can control up to three multi-jointed instruments and a fully articulating 3DHD endoscope. According to Intuitive, the system is currently approved for a wide range of surgical uses in the U.S., Japan, and South Korea, with evidence in more than 1,000 peer-reviewed publications supporting its safety, efficacy, and patient outcomes.
“Transvaginal procedures expand the natural orifice surgery portfolio of the da Vinci SP System, which to this day includes successful transoral and transanal procedures,” said Tilman Schlick, VP of medical affairs & medical officer at Intuitive in Europe. “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.”
