US-based medical device company Intuitive Surgical has received the US Food and Drug Administration (FDA) 510(k) approval for its next-generation multiport robotic system, da Vinci 5.

Da Vinci 5 is the latest addition to Intuitive’s da Vinci family of robotic surgical systems, which comprises da Vinci X and da Vinci Xi multiport systems, and the da Vinci SP single-port system.

The new device has been designed based on the company’s da Vinci Xi device, which has been used by surgeons and care teams in more than 7 million procedures worldwide.

Intuitive intends to commercialise Da Vinci 5 initially to limited US customers who collaborated with the company during its development and those with mature robotic surgery programs.

The medical device maker intends to work with surgeons at the initial sites to create additional data on the system’s use, prior a wider commercial roll-out.

Intuitive Surgical CEO Gary Guthart said: “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.”

The new-generation multiport robotic system features more than 150 enhancements.

Da Vinci 5 comes with design and engineering enhancements, including new surgeon controllers and powerful vibration and tremor controls, for improved accuracy and precision.

It features Intuitive’s high-quality and natural 3D imaging system that enables surgeons to support future generations of surgical endoscopes and vision software.

Da Vinci 5 launches Force Feedback technology and optional instruments that help the system to measure, and surgeons to feel, subtle forces exerted on tissue during surgery.

In preclinical trials, Force Feedback showed that surgeons needed up to 43% less force on tissue, which may translate to less trauma on tissue.

The system comes with advanced features, such as integrated key OR technologies, to help increase surgeon autonomy and streamline surgeon and care team workflow.

It also features an optimised user interface, with settings that can be accessed by the extended surgical team and by the surgeon directly from the head-in menu.

Furthermore, Da Vinci 5 has a redesigned console, allowing surgeons to make any necessary adjustments while their head is in the console, and is designed to fit different body types.

Intuitive chief medical officer Myriam Curet said: “We strive to provide customers with technology that meets their needs and solves important problems.

“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.”

“We design our systems so we can integrate new functions, capabilities, indications, and instrumentation over time.

“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.”