FDA clears labeling revision on da Vinci X and Xi for radical prostatectomy

The revision applies to the Precaution for Representative Uses statement.

The FDA has granted clearance to a labeling revision on the da Vinci X and Xi robotic systems pertaining to the use of the devices for radical prostatectomy, Intuitive Surgical announced in a news release.¹

Specifically, the revision applies to the Precaution for Representative Uses statement, which previously noted that the FDA did not evaluate outcomes with the device in the treatment of cancer. Now, the revised statement is as follows, with the change noted 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.”¹

The change to the statement was made following the submission of a real-world evidence study showing that 5- to 10-year overall survival following robot-assisted radical prostatectomy was comparable to that of non-robotic radical prostatectomy. The data were made available through a collaboration between Intuitive, the health care analytics company Aetion, and the National Evaluation System for health Technology (NEST), using the NEST Mark process to validate the data.

“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, MD, in the news release.¹ “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.”

Overall, the retrospective study included nearly 25,000 patients using de-identified health care claims data from the Optum Clinformatics Data Mart. The study evaluated overall survival following radical prostatectomy among patients who underwent robot-assisted surgery vs those who underwent open surgery in the United States. Patients included in the study all had treatment-naïve prostate cancer and underwent surgery between 2007 to 2014.

Additional news from Intuitive

In March 2024, Intuitive received FDA 510(k) clearance for the da Vinci 5, the company’s next-generation multiport robotic system.2 The da Vinci 5 system builds on the da Vinci Xi’s functional design with an inclusion of over 150 enhancements.

According to the new release from Intuitive,² the system was made available to a handful of customers in the United States who collaborated with the company during the development period as well as those with mature robotic surgery programs. Intuitive plans to work with surgeons at those sites to generate additional data on the system before it is made more widely available.

References

1. Intuitive announces FDA clearance of revised da Vinci Xi and X labeling on radical prostatectomy. News release. Intuitive Surgical, Inc. Published online and accessed June 5, 2024. https://isrg.intuitive.com/news-releases/news-release-details/intuitive-announces-fda-clearance-revised-da-vinci-xi-and-x

2. Intuitive announces FDA clearance of fifth-generation robotic system, da Vinci 5. News release. Intuitive Surgical, Inc. March 14, 2024. Accessed June 5, 2024. https://isrg.intuitive.com/news-releases/news-release-details/intuitive-announces-fda-clearance-fifth-generation-robotic