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August 3, 2017

FDA clears Standard Bariatrics’ new laparoscopic surgical clamp

Surgical procedure company Standard Bariatrics has obtained clearance from the US Food and Drug Administration (FDA) for the commercialisation of its new laparoscopic surgical clamp.

Surgical procedure company Standard Bariatrics has obtained clearance from the US Food and Drug Administration (FDA) for the commercialisation of its new laparoscopic surgical clamp.

The disposable Standard Clamp is intended for surgeons performing the laparoscopic sleeve gastrectomy weight loss surgery.

Surgeons use minimally invasive surgical tools and techniques during the sleeve gastrectomy procedure for removing around 80% of the stomach, creating a small sleeve or tubular pouch.

The new surgical device is developed to clamp the stomach’s entire length during the procedure, allowing surgeons to plan and hold the staple line before partitioning the stomach, instead of freehand stapling.

"The Standard Clamp solves an unmet clinical need by giving surgeons a tool that helps to enable consistent results while improving patient outcomes."

Standard Bariatrics president and CEO Matt Sokany said: “As demonstrated over months of clinical use, the Standard Clamp solves an unmet clinical need by giving surgeons a tool that helps to enable consistent results while improving patient outcomes.”

According to the firm’s founder and chief medical officer Jonathan Thompson, the new laparoscopic surgical clamp is designed to enable the creation of consistent sleeve gastrectomy anatomy, decrease surgical pouch variations, enhance the efficiency of the procedure, and minimise its overall cost.

The clamp is also intended to minimise variation and eliminate waste.

Standard Bariatrics intends to also introduce a laparoscopic stapler in the future to optimise surgical technique by allowing the surgeon to perform a consistent and repeatable sleeve gastrectomy procedure in a single firing.

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