Intuitive: FDA Clears Revised Da Vinci Xi, X Labeling; Confirms Non-inferiority For Overall Survival

(RTTNews) - Intuitive surgical (ISRG) announced the FDA cleared a labeling revision for da Vinci X and Xi specific to radical prostatectomy. The clearance was based on real-world evidence collected from 2007 to 2014 that showed overall five- to 10-year survival following robotic-assisted radical prostatectomy is similar to non-robotic radical prostatectomy.

The company said the labeling change applies specifically to the Precaution for Representative Uses statement for the da Vinci X and Xi systems. The previous precaution statement noted that the FDA did not review evaluation of outcomes related to the treatment of cancer.

Intuitive Chief Medical Officer Myriam Curet, said: "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."

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