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Intuitive Surgical’s Firefly Fluorescence Imaging Vision System FDA Cleared for Gallbladder Surgery

Fri, 09/27/2013 - 11:05am
Intuitive Surgical, Inc.

Intuitive Surgical, Inc., the global leader in minimally invasive robotic-assisted surgery, today announced it received FDA 510(k) clearance for expanded use of its da Vinci Fluorescence Imaging Vision System (Firefly) for the da Vinci Surgical System. Firefly imaging can now be used during gallbladder surgery.

The Firefly Fluorescence Imaging Vision System enables surgeons to use a special video camera and glowing dye to view blood flowing in vessels and tissue during minimally invasive surgical procedures. When a surgeon uses the Firefly camera, blood appears green and tissue without blood flow appears gray.

In addition to providing the ability to view blood flow through vessels and tissue, the expanded use now includes real-time imaging of bile ducts (cystic duct, common bile duct and common hepatic duct). The Firefly imaging system is intended for use along with normal white light in imaging of the bile ducts and is not intended for standalone use.

Injuries to the common bile duct represent a serious and challenging surgical complication, and most often occur during laparoscopic gallbladder removal.1 This occurs when the common bile duct is mistaken for the cystic duct, resulting in clipping and division of the common duct, which is then resected with the gallbladder.2 It is therefore beneficial in minimally invasive surgery to have the ability to properly identify the biliary duct.

"As a surgeon, real time and precise images during surgery are enormously helpful in achieving good patient outcomes," said Dr. Myriam Curet, Chief Medical Advisor, Intuitive Surgical. "Intuitive Surgical has been committed to surgical innovation for more than a decade, providing surgeons with not only improved surgical dexterity, but enhanced visualization during surgery. We will continue to innovate and enhance the da Vinci Surgical System to provide surgeons with tools that help deliver optimal patient outcomes."

For information on regulatory clearances, visit: http://www.intuitivesurgical.com/company/regulatory-clearance.html

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