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Intuitive Receives CE Mark for its da Vinci SP System

Intuitive has received CE mark approval for use in Europe for endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, transanal colorectal, and breast surgical procedures.

“We are pleased to receive CE mark for our da Vinci SP system, which offers surgeons across Europe the ability to perform more complex operations, across more patient types, in a minimally invasive way,” said Intuitive CEO Gary Guthart. “The da Vinci SP system represents the latest addition to our product portfolio in Europe and expands options for surgeons and hospitals seeking to provide patients with evidence-based, innovative care.”

The da Vinci SP system includes three, multi-jointed, wristed instruments and a fully wristed threedimensional (3D), high-definition (HD) camera. The instruments and the camera all emerge through a single cannula and are properly triangulated around the target anatomy at the distal tip.

The system enables flexible port placement and excellent internal and external range of motion (e.g., 360-degrees of anatomical access) through the single da Vinci SP system arm. Surgeons control the fully articulating instruments and the camera on the da Vinci SP system from a console.

“Surgeons in Europe have long been at the forefront of robotic-assisted surgery and have led the adoption of innovative care that offers meaningful patient benefits,” said Intuitive’s Senior Vice President and General Manager for Europe Dirk Barten.

“With the introduction of the da Vinci SP system, Intuitive continues to provide the latest technology to European surgeons and hospitals.”

A growing body of evidence – nearly 400 peer reviewed publications to date – supports the safety, efficacy and outcomes associated with the da Vinci SP system. The U.S. Food and Drug Administration has cleared the da Vinci SP system for certain urology procedures, including simple prostatectomy, as well as transoral otolaryngology procedures.

The da Vinci SP system is also approved for use in Japan and Korea for procedures across several disciplines.

Source: Intuitive

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