06.25.14
Sunnyvale, Calif.-based Intuitive Surgical Inc. has earned the CE mark for its Da Vinci Xi surgical system. The robotic system built for minimally invasive surgery received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in April.
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 it to optimize ease-of-use. For example, the system can help simplify procedures requiring access to multiple areas of the pelvis, abdomen or chest.
“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, vice president, sales and marketing, Europe, Middle East, India and Africa, 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 Da Vinci Xi 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 system. This month, Intuitive Surgical received the first of these clearances from the FDA to market the Endowrist One vessel sealer instrument for Da Vinci Xi in the United States.
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 (3 dimensional and high definition) visualization, intuitive motion and an ergonomic design. As with all Da Vinci Surgical Systems, Da Vinci Xi’s immersive 3D-HD vision system is meant to provide 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:
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 it to optimize ease-of-use. For example, the system can help simplify procedures requiring access to multiple areas of the pelvis, abdomen or chest.
“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, vice president, sales and marketing, Europe, Middle East, India and Africa, 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 Da Vinci Xi 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 system. This month, Intuitive Surgical received the first of these clearances from the FDA to market the Endowrist One vessel sealer instrument for Da Vinci Xi in the United States.
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 (3 dimensional and high definition) visualization, intuitive motion and an ergonomic design. As with all Da Vinci Surgical Systems, Da Vinci Xi’s immersive 3D-HD vision system is meant to provide 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; and
- Longer instrument shafts designed to give surgeons greater operative reach.