Intuitive Surgical (Sunnyvale, California), developer of robotic-assisted minimally invasive surgery products, said it has received a CE mark for its da Vinci Xi surgical system.
In April, the da Vinci Xi system received clearance from the FDA and is now commercialized in the U.S.
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 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.
With the U.S. and European introductions underway, Intuitive 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 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 U.S.
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.
Titan Spine receives TGA, MEDSAFE approvals
Titan Spine (Mequon, Wisconsin), a medical device surface technology company focused on developing spinal interbody fusion implants, reported that it has received separate registration approval from both the Australian Therapeutic Goods Administration and the New Zealand Medicines and Medical Devices Safety Authority to commercially market its full line of Endoskeleton interbody fusion devices in the two countries.
Kevin Gemas, president of Titan Spine, said the recent marketing authorization approvals in Australia and New Zealand "are a significant milestone for Titan Spine as they effectively expand the availability of our Endoskeleton interbody fusion devices to four broad global markets, including the United States and the European Union."
The full line of Endoskeleton devices features Titan Spine's proprietary implant surface technology, consisting of a combination of roughened topographies at the macro, micro, and cellular levels.
This combination of surface levels is designed to create an enhanced environment for bone growth at the cellular level, encouraging natural production of bone morphogenetic proteins (BMPs), and creating the potential for a faster and more robust fusion. //