Intuitive Surgical has obtained CE Mark approval for its da Vinci Xi system, a surgical platform designed to enable complex surgery using a minimally invasive approach.
The CE Mark approval allows the company to market its da Vinci Xi surgical system in Europe and other countries that require the CE Mark.
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.
Intuitive Surgical claims that the da Vinci Xi system is intended to be a technological leap forward in replacing large-incision open surgeries with a minimally invasive approach.
Designed to optimize ease-of-use, the da Vinci Xi System can help simplify procedures requiring access to multiple areas of the pelvis, abdomen or chest.
Intuitive Surgical obtained approval from the US Food and Drug Administration (FDA) for its da Vinci Xi system in April 2014.
In addition to US and European approvals, the company is seeking additional regulatory approvals 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.
The company received the first of these clearances from the FDA in June 2014 to market the EndoWrist One vessel sealer instrument for the da Vinci Xi system in the US.