The US Food and Drug Administration (FDA) has granted regulatory clearance for the da Vinci Single Port (SP) surgical system, developed by Intuitive, to be used in transanal local excision and resection procedures.
The decision broadens the system’s clinical applications in colorectal surgery, enabling minimally invasive intervention through a natural orifice without requiring abdominal incisions in selected procedures.
This clearance builds on the da Vinci SP system’s prior approvals issued in November 2024, which included transabdominal colorectal procedures such as low anterior resection, total mesorectal excision, colectomy, abdominoperineal resection, and sigmoidectomy.
Intuitive executive vice president and chief medical officer Myriam Curet said: “With FDA’s clearance of the da Vinci SP system for transanal local resection, surgeons have a new option in colorectal surgery to positively impact patient outcomes.
“Da Vinci SP represents a major leap forward for minimally invasive colorectal surgery, supporting surgeons in better preserving healthy tissue and accelerating patient recovery.”
The da Vinci SP system is engineered to address the challenges associated with operating in confined anatomical spaces such as the lower pelvis and rectum. It features a design that allows surgeons to operate three multi-jointed instruments and an articulating high-definition camera through a single incision site.
This architecture provides controlled access and flexibility in complex anatomical regions where conventional laparoscopic instruments face limitations.
The platform is positioned to address several limitations of laparoscopic transanal minimally invasive surgery. These include restricted manoeuvrability, ergonomics during extended procedures, and the technical complexity of reaching lesions in the upper rectum or performing circumferential resections in reverse orientation.
Unlike traditional transabdominal rectal resections that require multiple external incisions and removal of rectal tissue, the da Vinci SP system allows the procedure to be conducted entirely through a natural orifice. This technique may reduce external trauma and enhance surgical precision without compromising access or outcomes.
With this approval, Intuitive expands its colorectal surgical portfolio, which currently includes the da Vinci Xi and da Vinci 5 systems. Together, these platforms provide colorectal surgeons with an integrated set of tools for a broad range of procedures, each adapted to specific anatomical and procedural needs.
The da Vinci SP platform has already been cleared by the FDA for use in other disciplines. These include urology, where it is approved for procedures such as simple prostatectomy, as well as in transoral otolaryngology and general thoracoscopic surgeries.
In addition to the US, the system is also approved in Europe, Japan, and South Korea across multiple surgical specialisations.
Last month, Intuitive received FDA clearance for the SP SureForm 45 stapler, designed to be used with the da Vinci SP surgical system. The stapler features a fully wristed design and incorporates SmartFire technology, which continuously adjusts to tissue compression levels in real time to optimise staple line integrity and reduce the likelihood of tissue injury.
