Intuitive announced the FDA cleared a labelling revision for its da Vinci X and Xi surgical robotic platforms. It is based on real-world evidence collected from 2007-2014, and covers radical prostatectomy. Data showed similar overall five- to 10-year survival when comparing robotic-assisted radical prostatectomy to non-robotic procedures.
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da Vinci X and Xi, the previous generations behind the recently FDA-cleared da Vinci 5, now have a labelling change that applies specifically to the Precaution for Representative Uses statement. The previous statement noted that the FDA did not review the evaluation of outcomes related to the treatment of cancer. It reads as follows, with changes in bold:
Precaution for Representative Uses
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 following radical prostatectomy via robotic-assisted surgery as compared to open surgery among patients with treatment-naive prostate cancer in the U.S. 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.
da Vinci Xi, the world’s most widely used multiport robotic surgery system, offers capabilities for a range of procedures. It offers advanced instrumentation, vision, fluorescence imaging and integrated table motion. Intuitive describes its da Vinci X as a robotics program entry point, built on the same arm architecture as Xi. It enables the standardization of the same core instruments and vision technologies.
Intuitive worked with the FDA, Aetion and National Evaluation System for health Technology (NEST) to support the labeling update submission. The company says the project highlights the utility of this type of public-private collaboration to generate high-quality real-world evidence.
“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 Dr. Myriam Curet. “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.”
