Intuitive Surgical obtains CE mark for da Vinci 5 robot
The da Vinci 5 system includes numerous enhancements over the previous model. | Source: Intuitive Surgical
Intuitive Surgical Inc. yesterday said that its da Vinci 5 Surgical System has received CE mark approval for adult and pediatric use in Europe. The robot is allowed for minimally invasive endoscopic procedures across the abdominopelvic and thoracoscopic space, including urologic, gynecologic, and general laparoscopic procedures.
“At Intuitive, we’re focused on providing healthcare systems across Europe and around the world with thoughtful innovation that solves problems today and into the future,” stated Dave Rosa, CEO of Intuitive Surgical. “After over a decade of careful development, da Vinci 5 is the most advanced and integrated platform we’ve ever created – designed to enable better outcomes, efficiency, and insights for the future of minimally invasive care.”
Sunnyvale, Calif.-based Intuitive Surgical is a global leader in minimally invasive care and robot-assisted surgery. Its offerings include the da Vinci surgical system and the Ion endoluminal system. The company said it combines advanced systems, progressive learnings, and value-enhancing services to support the best patient outcomes possible.
da Vinci 5 designed for critical healthcare challenges
da Vinci 5 is Intuitive Surgical’s latest-generation robot. The company has designed several models of the surgical system, which includes high-definition 3D vision, a magnified view, and robotic and computer assistance.
The robots use specialized instrumentation, including a miniaturized surgical camera and wristed instruments such as scissors, scalpels, and forceps. All are designed to help with precise dissection and reconstruction deep inside the human body.
Intuitive said that da Vinci 5 is its smoothest and most precise multiport system to date. Its features more than 150 enhancements, including new surgeon controllers and vibration and tremor controls. The company said it designed da Vinci 5 to deliver:
- Enhanced surgical senses to support better patient outcomes, including Force Feedback-enabled technology, the most realistic 3D da Vinci vision system to date, and an ergonomic, immersive surgeon console to support surgeon career longevity.
- Operational efficiency, through greater surgeon autonomy with the integration of key components that surgeons can control at their fingertips. The system can also streamline workflows with an easy-to-learn system, a universal user interface for care teams, and integrated dynamic assistance to automate select tasks, said Intuitive.
- Actionable insights through an intelligent platform with 10,000 times more computing power and new sensors, software, and advanced processors. This provides surgeons with more usable data to help them quantify, understand, and improve their surgical performance for patients.
“We believe that the operational efficiencies and actionable insights provided by da Vinci 5 will not only help transform surgery but also help address critical challenges faced by healthcare systems across Europe,” said Dirk Barten, senior vice president and general manager for Europe at Intuitive.
Intuitive continues getting clearances
The U.S. Food and Drug Administration (FDA) last year granted Intuitive Surgical clearance for da Vinci 5, and the company began its commercial rollout in the U.S. this year.
Surgeons have used da Vinci systems in more than 410,000 procedures in Europe last year and nearly 17 million procedures to date, said Intuitive. The company has been developing systems for 30 years, and its said nearly 90,000 surgeons have been trained on its systems.
CE mark represents the latest regulatory milestone for Intuitive. In May, it received FDA clearance for a new indication for its da Vinci single-port (SP) surgical robot. Clearance extended da Vinci SP’s capabilities in colorectal surgery.
In June, surgeons used a da Vinci Xi system to perform what they claimed was the first robotic heart-transplant procedure in the U.S.
Also last month, Restore Robotics announced the first-in-human use of a remanufactured da Vinci Xi robotic instrument. The company holds the only clearance from the FDA to remanufacture these instruments, which it makes available to hospitals through Encore Medical Device Repair, its commercial partner. It led to a downgrade of Intuitive by Deutsche Bank, but BofA remained bullish.
“It’s exciting that surgeons and care teams across Europe will have their choice of the full portfolio of da Vinci systems, including da Vinci 5, giving them greater choice and flexibility, and ultimately supporting quality care for more patients across the region,” said Barten.
Editor’s note: This article was syndicated from The Robot Report sibling site MassDevice.
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