Intuitive Surgical
(Nasdaq: ISRG)
announced today that the FDA cleared its da Vinci SP surgical robot for simple prostatectomy.
The clearance, which includes prostatectomy as a representative procedure, expands da Vinci SP’s (single-port) available urologic surgical procedures. Sunnyvale, California-based Intuitive’s surgical robot now offers the removal of an enlarged prostate blocking urine flow with this procedure.
In the same action, the FDA cleared da Vinci SP for the transvesical approach to simple and radical prostatectomy. With this procedure, the surgeon removes the entire prostate gland, most often for those diagnosed with prostate cancer.
The da Vinci system offers robot-assisted technology for deep and narrow access to tissue in the body. Intuitive’s da Vinci system is considered the gold standard in robot-assisted laparoscopic surgery. However, da Vinci SP, while cleared in the U.S. for urology and transoral otolaryngology procedures, does not have clearance for general laparoscopic procedures. The system holds marketing authorization in Japan and Korea for a number of procedures across several disciplines.
It features three multi-jointed, wristed instruments and a fully wristed 3D high-definition camera. The instruments and camera emerge through a single cannula and triangulate around the target anatomy at the distal tip. This helps to avoid external instrument collisions that can occur in narrow surgical workspaces.
“The addition of simple prostatectomy and the transvesical approach to prostatectomy to the da Vinci SP clearances expands the existing urology indication for SP,” said Intuitive Chief Medical Officer Dr. Myriam Curet. “There is a growing body of clinical evidence on the use of the SP system, and we look forward to continuing our efforts to safely advance minimally invasive surgery.”