Intuitive said the FDA cleared the da Vinci Single Port (SP) surgical system for transanal local excision/resection, a form of minimally invasive surgery performed through a natural orifice to avoid abdominal surgical incisions for select procedures. This clearance extends the da Vinci SP’s capabilities in colorectal surgery, building upon procedures previously cleared by the FDA in November 2024, which include transabdominal procedures - low anterior resection, total mesorectal excision, colectomy, abdominoperineal resection, and sigmoidectomy.
Intuitive engineered the da Vinci SP system to navigate in narrow body cavities requiring precise access, such as lower pelvis and rectal procedures. Its design and architecture support access to rectal anatomy by allowing surgeons to control up to three multi-jointed instruments and a high-definition articulating camera through a single entry point to work freely in the smaller space.
Da Vinci SP also helps mitigate challenges inherent with laparoscopic transanal minimally invasive surgery, such as surgeon ergonomics, reaching lesions in the upper rectum, and working circumferentially, or “upside-down,” when needed.
The da Vinci SP system helps enable surgeons to dissect, suture, and excise through a natural orifice, avoiding external scarring for patients, unlike conventional transabdominal rectal resection, which typically requires multiple incisions and removal of the rectum.
This clearance adds to Intuitive’s colorectal portfolio, designed to meet the diverse needs of colorectal surgeons. With da Vinci 5 and da Vinci Xi, Intuitive provides colorectal surgeons with a broad, integrated offering to support a spectrum of colorectal interventions.
The FDA has previously cleared the da Vinci SP system for certain urology procedures, including simple prostatectomy, as well as transoral otolaryngology and general thoracoscopic procedures. The da Vinci SP system is also approved for use in Europe, Japan, and Korea for a range of procedures spanning multiple surgical disciplines.
