The biggest name in Robot MIS systems, Intuitive Surgical, Inc. says it has gained CE Mark approval for its da Vinci® Xi™ Surgical System, following its U.S. FDA clearance back in April.
We covered the da Vinci Xi platform’s features in April when we announced its U.S. clearance, so won’t re-hash them here. Suffice it to say that the company is saying its system is intended to be a technological leap forward in replacing large-incision open surgeries with a minimally invasive approach. The underpinning focus has been on improving ease of use, the company claiming its new system helps to simplify procedures requiring access to multiple areas of the pelvis, abdomen or chest.
With the U.S. and European introductions now underway then, 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, clearances which would 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.
Intuitive Surgical designed the new da Vinci Xi System to optimize ease-of-use. For example, the da Vinci Xi System can . 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.
The CE mark specifically indicates the system for assisting in the accurate control of Intuitive Surgical Endoscopic Instruments during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment.
“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.”
Source: Intuitive Surgical, Inc., Globe Newswire