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Friday, December 20, 2024

Intuitive secures FDA clearance for da Vinci 5 surgical robotic


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Intuitive surgical Da Vinci surgical system.

The entire Intuitive Surgical da Vinci 5 surgical robotic system. | Credit score: Intuitive Surgical

Intuitive Surgical (NASDAQ: ISRG) introduced right this moment that it secured FDA 510(okay) clearance for its next-generation da Vinci 5 multiport surgical robotics system. 

The information comes lower than two months after the dominant surgical robotics developer disclosed that it had submitted for the much-anticipated clearance, revealing the title of the brand new system within the course of. (Right here is our roundup of prime surgical robotics firms.)

Da Vinci joins a deep portfolio of options from Intuitive

The da Vinci 5 joins Intuitive’s current da Vinci robotic surgical system portfolio alongside the multiport X and Xi techniques and the single-port SP. There’s additionally Ion, Intuitive’s robotic-assisted platform for minimally invasive biopsy within the lung.

“We’re happy to obtain FDA clearance for our fifth-generation robotic system, da Vinci 5,” CEO Gary Guthart stated in a information launch after the market closed.

“Intuitive is dedicated to significant enhancements in surgical procedure that allow higher affected person outcomes, improve the affected person and care crew experiences, and finally decrease the overall price of care,” he continued. “After greater than a decade of cautious analysis, design, growth, and testing, we imagine da Vinci 5 will ship on these targets and assist drive the way forward for robotic-assisted surgical procedure.”

Da Vinci 5 options:

Intuitive shared extra particulars about how the da Vinci 5 improves on earlier da Vinci robots.

Intuitive Surgical da Vinci 5 tower.

The Intuitive Surgical da Vinci 5 tower [Image courtesy of Intuitive Surgical]

  • The corporate says new surgeon controllers and highly effective vibration and tremor controls make the da Vinci 5 the smoothest and most exact system it has developed to this point;
  • Intuitive says the da Vinci 5 has a next-generation 3D show and picture processing, offering a high-quality and pure imaging expertise. The objective is to allow surgeons to see extra right this moment and help future generations of surgical endoscopes and imaginative and prescient software program.
  • Da Vinci 5 introduces Pressure Suggestions expertise and non-compulsory devices that allow the system to measure and surgeons to really feel refined forces exerted on tissue throughout surgical procedure. Intuitive says this function is one thing no different surgical expertise in any modality presently affords. Intuitive says preclinical trials confirmed surgical procedures with Pressure Suggestions demonstrated as much as 43% much less power exerted on tissue, which might end in much less trauma on tissue.
  • Along with doubtlessly much less tissue trauma, Pressure Suggestions will add an vital new knowledge stream to surgical knowledge science, in line with Intuitive. (Notice: The Pressure Suggestions devices are non-compulsory to be used with da Vinci; they cleared for most of the similar procedures as da Vinci Xi.)
Intuitive Surgical da Vinci 5 insufflator.

The Intuitive Surgical da Vinci 5 insufflator [Image courtesy of Intuitive Surgical]

  • Da Vinci 5 additionally has options to assist improve surgeon autonomy and streamline surgeon and care crew workflow, boosting healthcare effectivity. ​For instance, da Vinci 5 has built-in key OR applied sciences, together with insufflation and an electrosurgical unit. There’s additionally an optimized consumer interface, with settings which might be accessible by the broader surgical crew and by the surgeon straight from the head-in menu. Plus, surgeons can entry different key settings whereas head-in to assist them keep centered on the surgical discipline.

  • Da Vinci 5 has greater than 10,000 instances the computing energy of da Vinci Xi. Intuitive says the drastically boosted computing energy permits progressive new system capabilities and superior digital experiences — now and sooner or later. There’s integration with Intuitive’s My Intuitive app, SimNow (digital actuality simulator), Case Insights (computational observer), and Intuitive Hub (edge computing system).
  • Options to extend surgeon consolation embrace a redesigned console able to customizable positioning, permitting surgeons to seek out their greatest match for surgical viewing and luxury. Surgeons even have the flexibility to sit down utterly upright. The surgeon could make any essential changes whereas their head is within the console. As well as, there are alternatives designed to suit completely different physique varieties, together with surgeons who’re pregnant.
Intuitive Surgical da Vinci 5’s surgeon console.

The Intuitive Surgical da Vinci 5’s surgeon console [Image courtesy of Intuitive Surgical]

Restricted availability for preliminary launch

Da Vinci 5 will initially be obtainable to a small variety of clients within the U.S. who collaborated with Intuitive in the course of the growth interval and people with mature robotic surgical procedure applications. The corporate’s objective is to work with surgeons at these preliminary websites to generate further knowledge on the system’s use earlier than a wider industrial introduction.

“We try to supply clients with expertise that meets their wants and solves vital issues,” stated Intuitive Chief Medical Officer Dr. Myriam Curet. “We intend to launch da Vinci 5 extra broadly within the U.S. and globally after we be taught from and work with an preliminary smaller variety of clients straight.”

Curet mentioned the key behind Intuitive’s surgical robotics success final 12 months with our sibling website Medical Design & Outsourcing.

For an inside take a look at what the Da Vinci 5 is able to, register now to attend DeviceTalks Boston. Intuitive EVP and Chief Digital Officer Brian Miller will overview among the futuristic performance of the brand new system in a closing keynote, “Intuitive: The Future is Now with da Vinci 5.”


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