Intuitive Surgical, Inc. (ISRG) revealed that it has received the U.S. Food and Drug Administration (FDA) clearance for using its da Vinci S(R) and da Vinci Si(R) Surgical Systems in benign, base of tongue resection procedures.
Tongue resection procedures are performed transorally, or through the mouth opening, by otolaryngologic surgeons, who specialize in diseases related to the ear, nose and throat (ENT). These surgical procedures include removal or resection of non-cancerous or benign tissue at the base of the tongue, near the opening of the throat.
Earlier, Intuitive Surgical's da Vinci S and da Vinci Si Surgical Systems were cleared for use in transoral otolaryngology procedures restricted to early stage benign or malignant (cancerous) tumors classified as T1 and T2.
Intuitive Surgical launched da Vinci Xi System in April this year. The new robotic surgical system offers advanced features over its original da Vinci Si System. However, it is not currently indicated for use in transoral otolaryngologic surgical procedures.
da Vinci Xi 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 clearance for using its da Vinci Fluorescence Imaging Vision System, well known as Firefly, as an optional feature in 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. It was the third FDA approval, Intuitive Surgical received for products related to the new da Vinci Xi System.
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 sport a Zacks Rank #1 (Strong Buy).
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