Intuitive Surgical Gets FDA Approval of Firefly for Xi

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Intuitive Surgical, Inc. (ISRG) revealed that it has received the U.S. Food and Drug Administration (:FDA) for using its da Vinci Fluorescence Imaging Vision System, well known as Firefly, as an optional feature in its newly launched robotic surgical system, da Vinci Xi. With the approval, the Sunnyvale, CA-based company will start shipping Firefly Imaging with all the da Vinci Xi Systems.

Intuitive Surgical launched Firefly in 2011 for use with the original da Vinci Si Surgical System in the U.S. and Europe. The system combines a fluorescent dye with a specialized camera, endoscope and laser-based illuminator to allow surgeons to identify vasculature in three dimensions beneath tissue surfaces.

The clearance means surgeons will be able to identify blood flowing in vessels and tissue during minimally invasive surgical procedures. While using the Firefly camera, tissue with blood appears green and the same without blood appears gray.

Firefly also helps surgeons identify the biliary duct properly for laparoscopic gallbladder removal surgeries. While performing surgeries, there is a higher chance of mistakenly identifying the cystic duct as bile duct leading to injuries due to clipping and division of the common duct.

Firefly Fluorescence Imaging Vision System helps surgeons use a specialized video camera to view real-time imaging of bile ducts (cystic duct, common bile duct and common hepatic duct). It enables surgeons to switch between standard, visible light and near-infrared imaging during minimally invasive procedures.

Prior FDA Approvals for Products Related to Xi

This is the third FDA approval, Intuitive Surgical received for products related to the new da Vinci Xi System since the latter launched in April this year. da Vinci Xi offers advanced features over its original da Vinci System. It includes wristed instruments, intuitive motion and an ergonomic design. Most notably, it enables 3D-HD visualization, which helps surgeons perform surgical procedures with a magnified view, virtually extending their eyes and hands into the patient.

Last month, Intuitive Surgical received FDA approval for the EndoWrist(R) Stapler 45 and Stapler white, blue and green reloads, which can be used with the da Vinci Xi. The EndoWrist Stapler provides wristed articulation and SmartClamp feedback, which detects if the stapler jaws are adequately closed on the tissue prior to firing.

The EndoWrist Stapler is made for resection, transection and creation of anastomoses (surgical connections between vessels or tissues) in gynecologic, general, urologic and thoracic surgeries.

In June this year, Intuitive Surgical also received U.S. FDA approval for the EndoWrist One Vessel Sealer instrument for the da Vinci Xi System. The EndoWrist Sealer is a fully wristed instrument than can be used for sealing and cutting vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.

Zacks Rank

Currently, Intuitive Surgical retains a Zacks Rank #3 (Hold). Some better-ranked stocks that are currently performing well in the medical instruments industry include Alphatec Holdings, Inc. (ATEC), ERBA Diagnostics, Inc. (ERB), and RTI Surgical Inc. (RTIX). All of these stocks carry a Zacks Rank #1 (Strong Buy).

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