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Product approval

Standard Bariatrics receives FDA clearance for Standard Clamp

Laparoscopic surgical device offers technical and clinical improvement for laparoscopic sleeve gastrectomy

Standard Bariatrics has received FDA clearance for the Standard Clamp, which according to the company, is a first-of-its-kind, disposable laparoscopic surgical clamp can assist surgeons performing laparoscopic sleeve gastrectomy, the most common and effective weight loss surgery. The company has begun commercial distribution of the product in the US.

 “We are extremely excited by the FDA’s clearance of the Standard Clamp,” said Matt Sokany, President and CEO of Standard Bariatrics. “The sleeve gastrectomy is already the number one bariatric surgical procedure. 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.”

The Standard Clamp is a laparoscopic surgical device designed to clamp the entire length of the stomach enabling surgeons to plan and hold the staple line prior to dividing the stomach during laparoscopic sleeve gastrectomy. Without the Standard Clamp, surgeons must freehand stapling producing inconsistent results.

“Developing bariatric surgical device innovations that enable surgeons to meet the various surgical needs of their patients is at the core of our culture,” said Dr Jonathan Thompson, Founder and Chief Medical Officer of Standard Bariatrics. “With FDA clearance of the Standard Clamp, bariatric surgeons now have a device that can help them create more consistent sleeve gastrectomy anatomy, minimizing surgical pouch variations, while improving procedure efficiency and reducing overall cost of the procedure.”

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