Intuitive Surgical’s da Vinci Xi surgical system receives FDA clearance

3 April 2014 (Last Updated April 3rd, 2014 01:00)

Intuitive Surgical has obtained US Food and Drug Administration (FDA) clearance for its da Vinci Xi System, the next-generation surgical robot designed to replace large-incision abdominal surgeries (open surgery) with a minimally invasive approach.

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IIntuitive Surgical has obtained US Food and Drug Administration (FDA) clearance for its da Vinci Xi System, the next-generation surgical robot designed to replace large-incision abdominal surgeries (open surgery) with a minimally invasive approach.

Intuitive said it plans to have its da Vinci Xi device immediately on the US market and will also be seeking regulatory clearances to market the da Vinci Xi System around the world.

Unlike previous generations of the da Vinci System, this system can be used across a wide spectrum of minimally invasive surgical procedures and has been optimised for complex, multi-quadrant surgeries.

Intuitive Surgical designed the new da Vinci Xi System with the goal of further advancing the technology used in minimally invasive surgery for complex diseases and conditions in gynaecology, urology, thoracic, cardiac and general surgery.

Intuitive Surgical president and CEO Gary Guthart said the company's goal is to develop technology that enhances surgical performance.

"The da Vinci Xi System's new overhead architecture means that multi-quadrant surgery can be performed without repositioning the system, an innovation long sought by surgeons who perform complex procedures," Guthart said.

"We strive to provide the most advanced, least invasive option for surgery, and we are working hard to make minimally invasive surgery the standard of care."

The da Vinci Xi System expands upon core da Vinci system features, including wristed instruments, 3D-HD visualisation, intuitive motion, and an ergonomic design.

Its immersive 3D-HD vision system provides surgeons a highly magnified view, virtually extending their eyes and hands into the patient.

"The da Vinci Xi System's new overhead architecture means that multi-quadrant surgery can be performed without repositioning the system, an innovation long sought by surgeons who perform complex procedures."

Compared with previous da Vinci Systems, the Xi version has a new overhead instrument arm architecture designed to facilitate anatomical access from virtually any position and a new endoscope digital architecture that creates a simpler, more compact design with improved visual definition and clarity.

It also improves the endoscope on the da Vinci Xi for a simpler, more compact design with improved visual definition and clarity and to enable it to be attached to any of the device's arms.

The new da Vinci also has longer instrument shafts to give surgeons greater operative reach.

In addition, the da Vinci Xi System is designed to be compatible with Intuitive Surgical's Firefly Fluorescence Imaging System, although the FDA has not cleared Firefly for use with the da Vinci Xi system.

The company plans to seek clearance for use of the Firefly with the da Vinci Xi and will continue to offer its previous da Vinci Si and Si-e systems.


Image: Intuitive's new da Vinci Xi robotic surgical system unveiled. Photo: ©[2014]Intuitive Surgical, Inc.