FDA OKs Revised Labeling for Intuitive’s da Vinci X & Xi

Intuitive has received U.S. Food and Drug Administration (FDA) clearance for a labeling revision for da Vinci X and Xi specific to radical prostatectomy.
 
The clearance was based on real-world evidence gathered from 2007-2014 showing five to ten-year survival after robotic-assisted radical prostatectomy is similar to non-robotic radical prostatectomy.
 
The label change applies to the Precaution for Representative Uses statement for da Vinci X and Xi. The prior precaution statement noted the FDA didn’t review evaluation of outcomes related to treating cancer.
 
The revised version is as follows:
 
“The demonstration of safety and effectiveness for the representative specific procedures did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence), except for radical prostatectomy which was evaluated for overall survival, or treatment of the patient’s underlying disease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.”
 
Intuitive provided data from a retrospective cohort study using de-identified healthcare claims data from the Optum Clinformatics Data Mart to evaluate overall survival after radical prostatectomy via robotic-assisted surgery, as compared to open surgery in U.S. patients with treatment-naive prostate cancer.
 
The study evaluation included nearly 25,000 patients, and the timeframe, 2007 to 2014, was chosen to avoid confounding factors related to the COVID-19 pandemic.
 
“We believe that many robotic procedures have advantages over traditional open surgery and laparoscopy for patients, care teams, and hospital customers—such as shorter hospital stays, fewer conversions, and less blood loss,” said Intuitive chief medical officer Myriam Curet, M.D. “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.”
 
Intuitive announced its next-gen da Vinci 5 surgical robot earned FDA clearance in March 2024.