In a significant development for robotic surgery, Intuitive Surgical Inc. announced yesterday that the U.S. Food and Drug Administration (FDA) has cleared a labeling revision for its da Vinci X and Xi surgical robotic platforms, specifically pertaining to radical prostatectomy procedures. This landmark decision is based on real-world evidence collected from 2007 to 2014, which 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 Surgical. "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."

The labeling revision applies specifically to the "Precaution for Representative Uses" statement for the da Vinci X and Xi platforms, the previous generations behind the recently FDA-cleared da Vinci 5. The previous statement noted that the FDA did not review the evaluation of outcomes related to the treatment of cancer. However, the updated statement now reads:

"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."

This labeling change is a significant milestone, as it acknowledges the long-term survival outcomes associated with robot-assisted radical prostatectomy procedures performed using Intuitive Surgical's da Vinci systems.

To support the labeling update submission, Intuitive Surgical provided data from a retrospective cohort study using de-identified healthcare claims data from the Optum Clinformatics Data Mart. The study evaluated overall survival following radical prostatectomy via robotic-assisted surgery compared to open surgery among nearly 25,000 patients with treatment-naive prostate cancer in the United States. The timeframe for the study was chosen to avoid confounding factors related to the COVID-19 pandemic.

Intuitive Surgical worked closely with the FDA, Aetion, and the National Evaluation System for Health Technology (NEST) to facilitate this labeling update, demonstrating the utility of public-private collaboration in generating high-quality, real-world evidence.

Beyond the labeling update, Intuitive Surgical's surgical robotics platforms are designed to offer capabilities for a range of procedures. The da Vinci Xi, for instance, offers advanced instrumentation, vision, fluorescence imaging, and integrated table motion, according to the company. The da Vinci X, described as a "robotics program entry point," 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.

Looking ahead, Intuitive Surgical plans to leverage the data collected by its newly FDA-cleared da Vinci 5 surgical robotics system to drive innovation and enhance patient care. Brian Miller, executive vice president and chief digital officer at Intuitive Surgical, emphasized the transformative potential of this data during a keynote presentation at DeviceTalks Boston 2024.

"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, responding to a question about the potential for future gains from hardware advances and data.

Miller further elaborated, "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 — 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."

Intuitive Surgical's focus on data-driven insights from its robotic platforms, combined with data from hospitals, aims to drive the next level of growth and innovation in patient care. By leveraging large volumes of data, the company can identify insights that could potentially revolutionize preoperative planning and surgical approaches.

As robotic surgery continues to evolve and gain traction in various medical specialties, this FDA labeling update and Intuitive Surgical's data-driven strategy underscore the growing acceptance and recognition of the potential benefits of these advanced technologies. With a commitment to generating real-world evidence and leveraging data to drive innovation, Intuitive Surgical is poised to play a pivotal role in shaping the future of robotic-assisted surgery and improving patient outcomes.