FDA Clears Standard Bariatrics’ Disposable Laparoscopic Surgical Clamp

Standard Bariatrics Inc., an innovator of bariatric surgical devices, has received U.S. Food and Drug Administration (FDA) clearance for the STANDARD CLAMP. The 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 United States.
 
“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 #1 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.”
 
More than 60 percent of patients seeking a surgical solution to weight loss choose the sleeve gastrectomy. During the procedure, surgeons utilize minimally invasive surgical tools and techniques to remove approximately 80 percent of the stomach, creating a small sleeve or tubular pouch. With the new, reduced stomach pouch patients will more quickly reach satiety, feeling satisfied after eating smaller amounts of food, which is one key component of losing weight and maintaining weight loss.
 
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 Jonathan Thompson, M.D. 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.”