SHERIDAN, WYOMING – May 7, 2025 – Intuitive (NASDAQ: ISRG), a global leader in robotic-assisted surgery, today announced the U.S. Food and Drug Administration (FDA) has granted clearance for its da Vinci Single Port (SP) surgical system for transanal local excision/resection. This clearance, which builds upon previous FDA approvals for transabdominal colorectal procedures, further enhances the capabilities of the da Vinci SP system, supporting minimally invasive surgery via natural orifice access.
Advancing Colorectal Surgery with Innovative Technology
The da Vinci SP system is designed to improve precision in surgeries that require access to narrow body cavities, such as those in the lower pelvis and rectum. By allowing surgeons to control up to three multi-jointed instruments and a high-definition articulating camera through a single entry point, the system offers enhanced freedom of movement in these smaller, more confined spaces.
“We are proud to announce the FDA’s clearance of the da Vinci SP system for transanal local resection,” said Myriam Curet, MD, Executive Vice President and Chief Medical Officer of Intuitive. “This system represents a significant advancement in minimally invasive colorectal surgery, enabling surgeons to better preserve healthy tissue and accelerate patient recovery, which can have a major positive impact on patient outcomes.”
Reducing the Need for External Incisions
One of the primary benefits of the da Vinci SP system is its ability to perform transanal local excision/resection without the need for abdominal incisions. Unlike conventional transabdominal rectal resections, which require multiple incisions and the removal of the rectum, the da Vinci SP offers a more patient-friendly approach by avoiding external scarring. This makes it a compelling option for surgeons looking to minimize the physical trauma associated with traditional surgical procedures.
Dr. Laila Rashidi, a colorectal surgeon at MultiCare Tacoma General Hospital, explained, “Using the da Vinci SP will help me adapt some of my transabdominal low anterior resections to transanal surgeries for appropriate lesions.” This shift to minimally invasive techniques is expected to improve surgical outcomes, reduce recovery time, and enhance the overall patient experience.
Expanding Colorectal Surgery Capabilities
This latest clearance adds to Intuitive’s extensive colorectal portfolio, which already includes the da Vinci 5 and da Vinci Xi systems. Together, these systems offer colorectal surgeons a broad, integrated suite of tools designed to support a wide range of colorectal interventions. The da Vinci SP system’s ability to navigate complex anatomical areas, such as the upper rectum, and handle circumferential surgeries with improved ergonomics, further cements its value in the field of colorectal surgery.
The system’s track record is supported by a growing body of evidence, including over 500 peer-reviewed publications that highlight the safety, efficacy, and positive patient outcomes associated with its use. It has already received FDA clearance for various urology, otolaryngology, and thoracoscopic procedures and is approved for use in Europe, Japan, and Korea.
A Milestone in Robotic-Assisted Surgery
Intuitive’s commitment to advancing surgical technology is underscored by its 30 years of innovation in robotic-assisted surgery. To date, nearly 17 million procedures have been performed using Intuitive’s systems, and more than 90,000 surgeons worldwide have been trained to operate these advanced technologies. As the company continues to push the boundaries of minimally invasive care, its goal remains clear: to improve patient outcomes, enhance the surgical experience, and reduce healthcare costs.
For more information, visit Intuitive's website.