Intuitive secures FDA clearance for da Vinci 5 surgical robot

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The complete Intuitive Surgical da Vinci 5 surgical robot system. | Credit: Intuitive Surgical

Intuitive Surgical (NASDAQ: ISRG) announced today that it secured FDA 510(k) clearance for its next-generation da Vinci 5 multiport surgical robotics system. 

The news comes less than two months after the dominant surgical robotics developer disclosed that it had submitted for the much-anticipated clearance, revealing the name of the new system in the process. (Here is our roundup of top surgical robotics companies.)

Da Vinci joins a deep portfolio of solutions from Intuitive

The da Vinci 5 joins Intuitive’s existing da Vinci robotic surgical system portfolio alongside the multiport X and Xi systems and the single-port SP. There is also Ion, Intuitive’s robotic-assisted platform for minimally invasive biopsy in the lung.

“We are pleased to receive FDA clearance for our fifth-generation robotic system, da Vinci 5,” CEO Gary Guthart said in a news release after the market closed.

“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,” he continued. “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 features:

Intuitive shared more details about how the da Vinci 5 improves on previous da Vinci robots.

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

• The company says new surgeon controllers and powerful vibration and tremor controls make the da Vinci 5 the smoothest and most precise system it has developed to date;
• Intuitive says the da Vinci 5 has a next-generation 3D display and image processing, providing a high-quality and natural imaging experience. The goal is to enable surgeons to see more today and support future generations of surgical endoscopes and vision software.
• 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. Intuitive says this feature is something no other surgical technology in any modality presently offers. Intuitive says preclinical trials showed surgeries with Force Feedback demonstrated up to 43% less force exerted on tissue, which could result in less trauma on tissue.
• In addition to potentially less tissue trauma, Force Feedback will add an important new data stream to surgical data science, according to Intuitive. (Note: The Force Feedback instruments are optional for use with da Vinci; they cleared for many of the same procedures as da Vinci Xi.)

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

• Da Vinci 5 also has features to help increase surgeon autonomy and streamline surgeon and care team workflow, boosting healthcare efficiency. ​For example, da Vinci 5 has integrated key OR technologies, including insufflation and an electrosurgical unit. There is also an optimized user interface, with settings that are accessible by the broader surgical team and by the surgeon directly from the head-in menu. Plus, surgeons can access other key settings while head-in to help them stay focused on the surgical field.

• Da Vinci 5 has more than 10,000 times the computing power of da Vinci Xi. Intuitive says the greatly boosted computing power enables innovative new system capabilities and advanced digital experiences — now and in the future. There is integration with Intuitive’s My Intuitive app, SimNow (virtual reality simulator), Case Insights (computational observer), and Intuitive Hub (edge computing system).
• Features to increase surgeon comfort include a redesigned console capable of customizable positioning, allowing surgeons to find their best fit for surgical viewing and comfort. Surgeons even have the ability to sit completely upright. The surgeon can make any necessary adjustments while their head is in the console. In addition, there are options designed to fit different body types, including surgeons who are pregnant.

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

Limited availability for initial release

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. The company’s goal is to 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 Chief Medical Officer Dr. Myriam Curet. “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.”

Curet discussed the secret behind Intuitive’s surgical robotics success last year with our sibling site Medical Design & Outsourcing.

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

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