The FDA has cleared the da Vinci SP surgical system from Intuitive for simple prostatectomy
DaVinci SP
According to Myriam Curet, M.D., Intuitive's Chief Medical Officer, the clearances represent an expansion of the existing urology indication for the da Vinci SP system. She stated that there is a growing body of clinical evidence on the use of the SP system and that they look forward to continuing their efforts to safely advance minimally invasive surgery.
The da Vinci SP system is designed to provide surgeons with robotic-assisted technology for deep and narrow access to body tissues. The system includes three multi-jointed, wristed instruments and a fully wristed three-dimensional (3D), high-definition (HD) camera that emerge through a single cannula, triangulated around the target anatomy at the distal tip to avoid external instrument collisions that can occur in narrow surgical workspaces.
Surgeons control the fully articulating instruments and the camera on the da Vinci SP system, which uses the same surgeon console as the da Vinci X and Xi systems, enabling flexible port placement and excellent internal and external range of motion. While the da Vinci SP system is cleared for urology and transoral otolaryngology procedures in the U.S., it is not approved for general laparoscopic surgery procedures.
Intuitive is a global leader in minimally invasive care and the pioneer of robotic surgery, headquartered in Sunnyvale, California. They aim to optimize care delivery to support the best outcomes possible with the help of digital intelligence, advanced systems, progressive learning, and value-enhancing services.
Intuitive, a leader in minimally invasive care and pioneer of robotic-assisted surgery, has received clearance from the Food and Drug Administration (FDA) for the da Vinci SP surgical system to perform simple prostatectomy and transvesical approach to simple and radical prostatectomy. These clearances expand the urologic surgical procedures that are now approved by the FDA. Simple prostatectomy involves the removal of a part of an enlarged prostate that is obstructing urine flow and is commonly performed on patients with benign prostatic hyperplasia (BPH). Radical prostatectomy, on the other hand, entails the complete removal of the prostate gland and is typically performed on patients diagnosed with prostate cancer.
The da Vinci SP system provides surgeons with robotic-assisted technology that facilitates deep and narrow access to tissues in the body. This system includes three multi-jointed wristed instruments and a fully wristed three-dimensional (3D), high-definition (HD) camera that emerge through a single cannula and are triangulated around the target anatomy at the distal tip. This design helps prevent external instrument collisions that may occur in narrow surgical workspaces. Surgeons control the fully articulating instruments and the camera, all of which are directed by the da Vinci SP system’s console, which is the same as the one used for the da Vinci X and Xi systems.
Intuitive’s Chief Medical Officer, Myriam Curet, M.D., stated that the clearances represent an expansion of the current urology indication for the da Vinci SP system. The da Vinci SP system has already been used for a variety of procedures across different medical disciplines in Japan and Korea. While the da Vinci SP system is cleared for urology and transoral otolaryngology procedures in the U.S., it is not approved for general laparoscopic surgery procedures. The da Vinci SP system is part of Intuitive’s portfolio of surgical systems, which has reached its fourth generation of innovative technology.
