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Incisionless Device to Revolutionize Treatment of Severe Metabolic Conditions

By HospiMedica International staff writers
Posted on 23 Jan 2024
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Image: ForePass is the first device truly designed to reverse insulin resistance and obesity (Photo courtesy of Keyron)
Image: ForePass is the first device truly designed to reverse insulin resistance and obesity (Photo courtesy of Keyron)

Metabolic surgery (MS) is a highly effective approach for treating obesity and type 2 diabetes, resulting in long-term weight loss and reversing numerous obesity-related comorbidities, including chronic inflammation, hypertension, and non-alcoholic fatty liver diseases such as nonalcoholic steatohepatitis (NASH). Now, an entirely incisionless device that replicates metabolic surgery without the need for surgical cuts could potentially surpass existing methods for managing metabolic conditions, offering a significant treatment alternative for those hesitant about invasive surgery or unresponsive to medications.

A study involving a prominent international team, including experts from King’s College London (London, UK), has highlighted the exceptional efficacy of the ForePass endoscopic, developed by Keyron (London, UK). This device remarkably treats severe obesity, type-2 diabetes, and metabolic dysfunction-associated steatohepatitis (MASH). ForePass uniquely combines a gastric balloon intersected by a central channel linked to a flexible intestinal sleeve. This design emulates the mechanism of invasive metabolic surgery without actual surgery or incisions. The device is inserted into the stomach and the initial part of the small intestine through endoscopy, a procedure far less invasive and more cost effective than traditional metabolic surgery.

ForePass is engineered to reduce food intake, leading to significant weight loss, and directs food deeper into the gut, improving insulin resistance. This mechanism effectively treats or potentially reverses diabetes and serious liver conditions like MASH. Notably, unlike metabolic surgery, ForePass is fully reversible, adding to its appeal for patients. The study's focus was to assess the ForePass device's impact on weight, insulin sensitivity, and fecal microbiota in pigs, in comparison to a control group not undergoing the procedure. After a month of implantation, the ForePass device demonstrated a significant 79% reduction in weight gain and notable improvements in glucose balance, compared to the control animals.

Moreover, the device positively influenced fecal microbiota, enhancing bacteria associated with metabolic health. These results are indicative of a reversal in severe obesity, diabetes, and MASH, signifying an overall enhancement in metabolic health. Keyron is planning to commence clinical trials for the ForePass device, expected to begin in early 2025. If these trials confirm the safety and efficacy observed in animal studies, this device holds the potential to dramatically transform the treatment landscape for severe obesity in the coming years.

“The ForePass device will be a game-changer for treating severe metabolic conditions. It replicates the effects of metabolic surgery without invasive procedures and without making any cuts to internal organs,” said Dr. Manoel Galvao Neto, endoscopic surgeon and researcher, who led the study. “It’s the first device of its kind and will pave the way for a new era in managing severe metabolic conditions.”

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