Intuitive earns up to date FDA labeling on da Vinci X, Xi for radical prostatectomy


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The Da Vinci Xi robotic surgery system.

The da Vinci Xi robotic surgical procedure system. | Supply: Intuitive Surgical

Intuitive Surgical Inc. yesterday introduced that the U.S. Meals 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 primarily based on real-world proof collected from 2007 to 2014 that demonstrated the same five- to 10-year survival interval between robot-assisted radical prostatectomy procedures and non-robotic procedures.

“We consider that many robotic procedures have benefits over conventional open surgical procedure and laparoscopy for sufferers, care groups, and hospital clients—akin to shorter hospital stays, fewer conversions, and fewer blood loss,” acknowledged Myriam Curet, M.D., chief medical officer at Intuitive. “This can be a vital step as a result of it confirms non-inferiority for total survival at 10 years for sufferers present process radical prostatectomy with the da Vinci surgical system.”

FDA updates surgical robotic label

da Vinci X and Xi, the earlier generations behind the recently FDA-cleared da Vinci 5, now have a labeling change that applies particularly to the “Precaution for Consultant Makes use of” assertion. The earlier assertion famous that the FDA didn’t evaluate the analysis of outcomes associated to the therapy of most cancers. It now reads as follows, with adjustments in daring:

Precaution for Consultant Makes use of

The demonstration of security and effectiveness for the consultant particular procedures didn’t embrace analysis of outcomes associated to the therapy of most cancers (total survival, disease-free survival, native recurrence), aside from radical prostatectomy which was evaluated for total survival, or therapy of the affected person’s underlying illness/situation. System utilization in all surgical procedures needs to be guided by the scientific judgment of an adequately skilled surgeon.

Intuitive offered information from a retrospective cohort research utilizing de-identified healthcare claims information from the Optum Clinformatics Information Mart to guage total survival following radical prostatectomy through robotic-assisted surgical procedure as in comparison with open surgical procedure amongst sufferers with treatment-naive prostate most cancers within the U.S. The research analysis included almost 25,000 sufferers, and the timeframe was chosen to keep away from confounding elements associated to the COVID-19 pandemic.


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da Vinci designed for a variety of procedures

da Vinci Xi affords capabilities for a variety of procedures, in accordance with Intuitive Surgical. The multiport robotic surgical procedure system offers superior instrumentation, imaginative and prescient, fluorescence imaging, and built-in desk movement.

Intuitive described its da Vinci X as a “robotics program entry level.” It’s constructed on the identical arm structure because the Xi and is designed to allow the standardization of the identical core devices and imaginative and prescient applied sciences, stated the corporate.

Intuitive labored with the FDA, Aetion, and Nationwide Analysis System for Well being Know-how (NEST) to assist the labeling replace submission. It asserted that the undertaking demonstrates the utility of public-private collaboration to generate high-quality, real-world proof.

Intuitive plans to make use of information to drive innovation

Information collected by Intuitive Surgical’s new da Vinci 5 surgical robotics system goes to be “unbelievably transformational” for affected person care, stated Brian Miller, government vp and chief digital officer at Intuitive. In a keynote presentation at DeviceTalks Boston 2024, he claimed that the fifth-generation DV5 is probably the most exact robotic Intuitive has ever constructed.

“What I imply by that’s the skill to calculate precisely the place the tip of the robotic is, is the very best precision that we’ve achieved. That includes higher-resolution sensors, higher motors. You’ll proceed to see these developments within the platform,” Miller stated in response to a query from DeviceTalks Editorial Director Tom Salemi in regards to the potential for future features from {hardware} advances and information.

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

“However I do personally consider that the information that’s coming from the robotic system and the power to characterize that process — what occurred, what know-how did they use, how did they method it,” stated Miller. “You couple that with the result standing at some hospitals, I feel that it’s going to be an unbelievably transformational know-how to have the ability to say the way you method affected person care. … Oftentimes, it’s the method that it is advisable to discover, and there’s quite a lot of preoperative planning in place.”

Miller shared that Intuitive is specializing in “data-driven insights that come from the robotic platform — in addition to information that the hospital has — to actually drive the subsequent degree of progress in innovation sooner or later.” The corporate can establish these insights by massive volumes of information, he stated.

Editor’s word: This text was syndicated from The Robotic Report’s sibling website MassDevice.

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