Intuitive's da Vinci SP single‑port surgical system has secured CE mark clearance for transvaginal gynaecological procedures, extending its authorised uses across Europe. The system operates via a single incision or natural orifice and supports up to three multi‑jointed instruments plus an articulating 3DHD endoscope. Company leaders say the approval broadens scarless, minimally invasive options that may shorten recovery times. The platform already has approvals in Japan, Korea and the United States.
Intuitive's da Vinci SP Gains CE Mark for Transvaginal Gynaecological Use, Expanding Minimally Invasive Options in Europe
The da Vinci SP system enables surgeons to carry out operations via a single incision or natural orifice. Credit: Intuitive / PRNewswire.
Intuitive has received CE mark clearance allowing its da Vinci SP (Single Port) surgical system to be used for transvaginal gynaecological procedures across Europe. The decision expands the platform’s authorised applications in European markets and broadens minimally invasive options available to women.
The da Vinci SP system is already approved in Europe for breast surgery, endoscopic abdominopelvic procedures, thoracoscopic operations, transanal colorectal interventions and transoral otolaryngology. The new approval enables clinicians to offer transvaginal approaches in addition to these established uses.
The platform is designed to operate through a single incision or a natural orifice. It supports up to three multi-jointed instruments and an articulating 3DHD endoscope, all deployed and controlled through a single entry point. This configuration aims to reach complex anatomical spaces while minimising disruption to surrounding tissue and reducing visible scarring.
Dirk Barten, Commercial President of Intuitive 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, Vice-President Medical Affairs and Medical Officer, Intuitive Europe: "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."
Beyond Europe, the da Vinci SP system holds regulatory approvals for various procedures in Japan, Korea and the United States. Intuitive is headquartered in Sunnyvale, California, with its European base in Aubonne, Switzerland.
Source: Medical Device Network (a GlobalData brand)
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