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Editor’s Notice: This text was syndicated from The Robotic Report’s sibling web site MassDevice.
The da Vinci Xi robotic surgical procedure system. | Supply: Intuitive Surgical
Intuitive Surgical Inc. yesterday introduced yesterday 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 based mostly on real-world proof collected from 2007 to 2014 that demonstrated an analogous five- to 10-year survival interval between robot-assisted radical prostatectomy procedures and non-robotic procedures.
“We imagine that many robotic procedures have benefits over conventional open surgical procedure and laparoscopy for sufferers, care groups, and hospital clients—corresponding to shorter hospital stays, fewer conversions, and fewer blood loss,” said Myriam Curet, M.D., chief medical officer at Intuitive. “This can be a important step as a result of it confirms non-inferiority for general 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 not too long ago 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 assessment the analysis of outcomes associated to the therapy of most cancers. It now reads as follows, with modifications 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 (general survival, disease-free survival, native recurrence), aside from radical prostatectomy which was evaluated for general survival, or therapy of the affected person’s underlying illness/situation. Gadget utilization in all surgical procedures ought 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 general 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 practically 25,000 sufferers, and the timeframe was chosen to keep away from confounding components associated to the COVID-19 pandemic.
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da Vinci designed for a variety of procedures
da Vinci Xi provides capabilities for a variety of procedures, based on Intuitive Surgical. The multiport robotic surgical procedure system provides 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 Expertise (NEST) to help the labeling replace submission. It asserted that the mission 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 vice chairman 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 potential to calculate precisely the place the tip of the robotic is, is the best precision that we’ve completed. That entails 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 positive aspects from {hardware} advances and information.
DeviceTalks is produced by WTWH Media, which additionally publishes MassDevice and The Robotic Report.
“However I do personally imagine that the information that’s coming from the robotic system and the flexibility to characterize that process — what occurred, what know-how did they use, how did they strategy it,” stated Miller. “You couple that with the result standing at some hospitals, I believe that it’s going to be an unbelievably transformational know-how to have the ability to say the way you strategy affected person care. … Oftentimes, it’s the strategy that you should discover, and there’s loads 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 following stage of development in innovation sooner or later.” The corporate can establish these insights by means of massive volumes of information, he stated.
