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Intuitive Wins FDA Clearance of Fifth-Generation Robotic System, da Vinci 5


Intuitive (NASDAQ:ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, announced today that the U.S. Food and Drug Administration (FDA) provided 510(k) clearance for da Vinci 5, the company’s next-generation multiport robotic system.

“We are pleased to receive FDA clearance for our fifth-generation robotic system, da Vinci 5,” said Gary Guthart, CEO. “Intuitive is committed to meaningful improvements in surgery that enable better patient outcomes, enhance the patient and care team experiences, and ultimately lower the total cost of care. After more than a decade of careful research, design, development, and testing, we believe da Vinci 5 will deliver on these goals and help drive the future of robotic-assisted surgery.”

Da Vinci 5 builds on Intuitive’s da Vinci Xi’s highly functional design, which surgeons and care teams around the world have used in more than 7 million procedures to date. The system includes more than 150 enhancements, including:

  • Improved accuracy and precision: Da Vinci 5’s design and engineering enhancements, including new surgeon controllers and powerful vibration and tremor controls, make it the smoothest and most precise system Intuitive has developed to date.
  • Next-generation 3D display and image processing: Da Vinci 5 is equipped with Intuitive’s highest quality and most natural 3D imaging system, enabling surgeons to see more today, and supporting future generations of surgical endoscopes and vision software as those technologies evolve.
  • First-of-its-kind force-sensing technology: Da Vinci 5 introduces Force Feedback technology and optional instruments that enable the system to measure, and surgeons to feel, subtle forces exerted on tissue during surgery —something no other surgical technology in any modality offers. In preclinical trials with surgeons at all experience levels, Force Feedback demonstrated up to 43 percent less force exerted on tissue, which may translate to less trauma on tissue. The ability to measure this force adds an important new data stream to surgical data science, which can bring future analytical insights supported through artificial intelligence. Force Feedback instruments, which are optional for use with da Vinci 5, are cleared for use in the same procedures as da Vinci Xi, except pediatric and cardiac procedures, and a specific contraindication for the Force Feedback needle driver for use in suturing during hysterectomy and myomectomy procedures.
  • Meaningful throughput and workflow enhancements: Da Vinci 5 has innovative features that are designed to help increase surgeon autonomy and streamline surgeon and care team workflow. ​For example, da Vinci 5 has integrated key OR technologies, including insufflation and an electrosurgical unit. The system also includes an optimized user interface, with settings that are accessible by the broader surgical team and by the surgeon directly from the head-in menu. Surgeons have access to other key settings while head-in to help them stay focused on the surgical field.

    Together, these innovations will continue to streamline workflow in the OR and potentially save valuable time, without compromising patient safety. This can enable more efficient use of a hospital’s human and capital resources.
  • Expanded computing power and advanced data capabilities: Da Vinci 5 has more than 10,000 times the computing power of da Vinci Xi. This enables innovative new system capabilities and advanced digital experiences, now and in the future, including integration with Intuitive’s My Intuitive app, SimNow (virtual reality simulator), Case Insights (computational observer), and Intuitive Hub (edge computing system).
  • Greater surgeon comfort: The system features a redesigned console capable of customizable positioning, allowing surgeons to find their best fit for surgical viewing and comfort, including the ability to sit completely upright. The surgeon can make any necessary adjustments while their head is in the console, with options designed to fit different body types, including surgeons who are pregnant.

Da Vinci 5 will initially be available to a small number of customers in the U.S. who collaborated with Intuitive during the development period and those with mature robotic surgery programs. Intuitive will work with surgeons at these initial sites to generate additional data on the system’s use before a wider commercial introduction.

“We strive to provide customers with technology that meets their needs and solves important problems,” said Intuitive’s Chief Medical Officer, Myriam J. Curet, M.D. “We intend to launch da Vinci 5 more broadly in the U.S. and globally after we learn from and work with an initial smaller number of customers directly.”

Da Vinci 5 is the latest addition to the da Vinci family, which includes multiport systems da Vinci X and da Vinci Xi, and the single-port system da Vinci SP. These offer surgeons and hospitals their choice of highly capable, proven solutions from Intuitive.

“We design our systems so we can integrate new functions, capabilities, indications, and instrumentation over time,” said Curet. “Our careful attention to customers’ long-term needs and goals has led our systems to become the hospital standard, and we expect to continue developing and innovating da Vinci 5 and da Vinci Xi over the coming years.”

Source: Intuitive

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