hapabapa Intuitive Surgical ( NASDAQ: ISRG ) announced Wednesday that the U.S. Food and Drug Administration (FDA) greenlighted a label revision for its robotic surgical systems, da Vinci X and da Vinci Xi, to allow their use in the removal of the prostate gland.
The decision validates the use of da Vinci X and Xi in radical prostatectomy, a medical procedure used to remove the prostate gland and related structures after cancer diagnosis. The labeling revision was backed by real-world data from 2007 to 2014, indicating similar rates of five- to 10-year survival data following robotic-assisted and non-robotic radical prostatectomy. Nearly 25,000 U.
S. patients who underwent surgery for treatment-naive prostate cancer represented the data sample. “This is a significant step because it confirms non-inferiority for overall survival at 10 years for patients undergoing radical prostatectomy with the da Vinci surgical system,” Myriam Curet, Intuitive Surgical’s ( ISRG ) medical chief, remarked.
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