Intuitive earns updated FDA labeling on da Vinci X, Xi for radical prostatectomy

Intuitive Surgical Inc. yesterday announced that the U.S. Food and Drug Administration has cleared a labeling revision for its da Vinci X and Xi surgical robotic platforms and radical prostatectomy.

The labeling revision was based on real-world evidence collected from 2007 to 2014 that demonstrated a similar five- to 10-year survival period between robot-assisted radical prostatectomy procedures and non-robotic procedures.

“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,” stated Myriam Curet, M.D., chief medical officer at Intuitive. “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.”

FDA updates surgical robot label

da Vinci X and Xi, the previous generations behind the recently FDA-cleared da Vinci 5, now have a labeling 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 now 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 was chosen to avoid confounding factors related to the COVID-19 pandemic.

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da Vinci designed for a range of procedures

da Vinci Xi offers capabilities for a range of procedures, according to Intuitive Surgical. The multiport robotic surgery system offers advanced instrumentation, vision, fluorescence imaging, and integrated table motion.

Intuitive described its da Vinci X as a “robotics program entry point.” It is built on the same arm architecture as the Xi and is designed to enable the standardization of the same core instruments and vision technologies, said the company.

Intuitive worked with the FDA, Aetion, and National Evaluation System for Health Technology (NEST) to support the labeling update submission. It asserted that the project demonstrates the utility of public-private collaboration to generate high-quality, real-world evidence.

Intuitive plans to use data to drive innovation

Data collected by Intuitive Surgical’s new da Vinci 5 surgical robotics system is going to be “unbelievably transformational” for patient care, said Brian Miller, executive vice president and chief digital officer at Intuitive. In a keynote presentation at DeviceTalks Boston 2024, he claimed that the fifth-generation DV5 is the most precise robot Intuitive has ever built.

“What I mean by that is the ability to calculate exactly where the tip of the robot is, is the highest precision that we’ve done. That involves higher-resolution sensors, better motors. You will continue to see those advancements in the platform,” Miller said in response to a question from DeviceTalks Editorial Director Tom Salemi about the potential for future gains from hardware advances and data.

DeviceTalks is produced by WTWH Media, which also publishes MassDevice and The Robot Report.

“But I do personally believe that the data that is coming from the robotic system and the ability to characterize that procedure — what happened, what technology did they use, how did they approach it,” said Miller. “You couple that with the outcome status at some hospitals, I think that it’s going to be an unbelievably transformational technology to be able to say how you approach patient care. … Oftentimes, it’s the approach that you need to find, and there’s a lot of preoperative planning in place.”

Miller shared that Intuitive is focusing on “data-driven insights that come from the robotic platform — as well as data that the hospital has — to really drive the next level of growth in innovation in the future.” The company can identify those insights through large volumes of data, he said.

Editor’s note: This article was syndicated from The Robot Report’s sibling site MassDevice.