Abstract
Intuitive Surgical, Inc. the global leader in minimally invasive robotic-assisted surgery, has announced that it has received FDA clearance to market its Single-Site Instrumentation for laparoscopic cholecystectomy procedures. The company already has CE mark approval in Europe.
Single-Site Instrumentation provides da Vinci Si customers with a technology that enables cholecystectomy via a single incision, while providing the benefits of traditional multi-port da Vinci Surgery— enhanced surgical precision, control and stability and 3D HD visualization. All da Vinci Si Surgical Systems are compatible with Single-Site™ Technology. The standard da Vinci and the da Vinci S Systems are however not compatible with Single-Site Technology.
The system
The Single-Site suite of instruments and accessories consists of the Single-Site Port, specialized curved cannulae and 5mm semi-rigid instruments, which are compatible with any da Vinci Si Surgical System. The design of the instruments and the da Vinci System’s Remote Center Technology are intended to reduce instrument crowding and external collisions typically associated with hand-held, laparoscopic single-incision devices.
Company comments
Gary Guthart, CEO, Intuitive Surgical Inc., stated, “We are pleased with this clearance for our Single-Site instruments for use in laparoscopic cholecystectomy using the da Vinci System. We plan to immediately initiate a controlled rollout of these products in the US, while continuing our rollout in Europe. As we learn more about our customers’ needs within single-incision surgery, we anticipate future submissions to the US FDA and other global regulatory agencies related to expansion of the cleared indications for use, as well as additional Single-Site instruments.”
Source: Intuitive Surgical
Image ©2011 Intuitive Surgical, Inc
published: December 15, 2011 in: Approval/Clearance, General Surgery, Regulatory, Specialty, Techniques