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Intuitive Surgical Receives CE Mark for the da Vinci Xi Surgical System

Wed, 06/25/2014 - 9:16am
Globe Newswire

Intuitive Surgical, Inc., the global leader in robotic-assisted minimally invasive surgery, today announced it has received a CE Mark for its da Vinci Xi Surgical System. Achieving this milestone allows the company to market the Xi System in Europe and other countries that require the CE Mark. In April, the da Vinci Xi System received clearance from the U.S. Food and Drug Administration (FDA) and is now commercialized in the United States.

The da Vinci Xi System is intended to be a technological leap forward in replacing large-incision open surgeries with a minimally invasive approach. Intuitive Surgical designed the new da Vinci Xi System to optimize ease-of-use. For example, the da Vinci Xi System can help simplify procedures requiring access to multiple areas of the pelvis, abdomen or chest. For more than a decade, da Vinci Surgical Systems have enabled surgeons to offer a minimally invasive alternative to open surgery that aims to reduce many of the costs and complications associated with open procedures.

"We are pleased to bring the da Vinci Xi System to market in Europe and other countries that rely on the CE Mark for marketing authorization," said Henry Charlton, Intuitive Surgical Vice President, Sales and Marketing, Europe, Middle East, India and Africa (EMEIA), Latin America, Canada and Australia. "With the CE Mark, we're expanding our customer base that has access to this exciting new technology. The da Vinci Xi System represents the most advanced option available to date as we strive to make minimally invasive surgery the global standard of care."

With the U.S. and European introductions underway, Intuitive Surgical is seeking additional regulatory clearances to market the da Vinci Xi System around the world. These include clearances for advanced technologies such as vessel sealing, stapling and fluorescence imaging, which are designed to enhance the capabilities of the da Vinci Xi System. This month, Intuitive Surgical received the first of these clearances from the FDA to market the EndoWrist One Vessel Sealer instrument for the da Vinci Xi System in the United States.

Efficient Anatomical Access, Crystal Clear 3D-HD Visualization
By enabling efficient access throughout the pelvis, abdomen and chest, the da Vinci Xi System expands upon the core da Vinci System features, which include wristed instruments, 3D-HD visualization, intuitive motion and an ergonomic design. As with all da Vinci Surgical Systems, the da Vinci Xi System's immersive 3D-HD vision system provides surgeons with a highly magnified view, virtually extending their eyes and hands into the patient.

Compared with prior da Vinci Systems, the da Vinci Xi System's key features include:

  • A new overhead instrument arm architecture designed to facilitate anatomical access from virtually any position.
  • A new endoscope digital architecture that creates a simpler, more compact design with improved visual definition and clarity.
  • An ability to attach the endoscope to any arm, providing flexibility for visualizing the surgical site.
  • Smaller, thinner arms with newly designed joints that offer a greater range of motion than ever before.
  • Longer instrument shafts designed to give surgeons greater operative reach.

A System Designed For the Future
The da Vinci Xi System is an expandable technology platform that is designed to accommodate and seamlessly integrate a range of current technologies in areas such as fluorescence imaging, advanced instruments and anatomical access, as well as future innovations.

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