Intuitive Surgical Single-Site Needle Driver Cleared by FDA - Analyst Blog

Intuitive Surgical, Inc. (ISRG) revealed that it has received U.S. Food and Drug Administration (FDA) clearance for Single-Site Wristed Needle Driver for use in single-incision surgery with the company's da Vinci Si robotic surgical System.

The clearance allows use of another instrument under Single-Site suite for minimally invasive removal of the uterus (hysterectomy), the ovaries, and fallopian tubes for benign conditions, as well as removal of the gallbladder.

Single-Site Instrumentation leads to scar-less surgeries through a single-incision. It gives the benefits of robotic and computer assistance to surgeons.

The 5 mm Single-Site Wristed Needle Driver was also developed to facilitate suturing after removal of the uterus. It can lead to movement of up to 45 degrees of the instrument tip in all directions for precise needle positioning. These apart, it also features serrated jaws to facilitate needle handling.

The FDA clearance allows sale of the Single-Site Wristed Needle Driver in the U.S. Intuitive Surgical will now seek regulatory approvals for selling the product across the world.

Recently, Intuitive Surgical received 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. It was the third FDA approval, Intuitive Surgical received for products related to the new da Vinci Xi System.

Socks that are currently performing well in the medical instruments industry include Alphatec Holdings, Inc. (ATEC), ERBA Diagnostics, Inc. (ERB), and Edwards Lifesciences Corp. (EW).