Intuitive has received CE mark approval for the indication of transvaginal gynaecologic procedures for the da Vinci SP (Single Port) surgical system.
The approval marks the first indication for transvaginal use of the da Vinci SP system and expands its CE-marked applications in Europe.
The system is currently approved in Europe for a range of procedures, including endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, transanal colorectal and breast surgeries.
“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,” said Dirk Barten, commercial president for Europe at Intuitive.
The da Vinci SP system allows surgeons to perform procedures through a single incision or natural orifice, offering enhanced visualisation and precision in narrow or deep anatomical spaces.
Through a single entry point, surgeons can control up to three multi-jointed instruments along with a fully articulating 3DHD endoscope. The system is designed to provide access to complex anatomy while minimising disruption to surrounding tissue.
“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, vice president, medical affairs and 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,” he added.
According to Intuitive, more than 1,000 peer-reviewed publications have supported the safety, efficacy and patient outcomes associated with the da Vinci SP system. The system is also approved in the US, Japan and South Korea for procedures across multiple surgical specialties.
Intuitive expands da Vinci 5 capabilities in Europe
The latest approval follows Intuitive’s recent announcement of CE mark approval for Force Feedback instruments for its da Vinci 5 surgical system.
The Force Feedback technology is designed to enhance intra-operative awareness of the forces applied to tissue during surgery. It allows surgeons to feel push and pull forces through their da Vinci 5 console hand controls and measure these forces through a real-time force indicator.
Alongside Force Feedback instruments, Intuitive is introducing more than 100 updates and user experience enhancements for da Vinci 5 users in Europe.
“With the introduction of Force Feedback instruments and new capabilities for da Vinci 5 in Europe, we continue to deliver on our vision of a future-ready platform that can evolve with the needs of surgeons, patients and health systems,” Barten said.
The da Vinci 5 is the fifth-generation da Vinci surgical system and the latest addition to Intuitive’s portfolio. The company’s portfolio also includes the multiport da Vinci X and da Vinci Xi systems and the single-port da Vinci SP system.
