RESET® is an endoscopically delivered medical device intended to help restore healthy blood sugar levels and reduce weight. RESET® is an investigational medical device for people living with uncontrolled type 2 diabetes and obesity that is sought to bridge the gap between partially effective medications, insulin injections, and irreversible surgery.
RESET® is a thin, flexible 60 cm sleeve that is endoscopically implanted within the small intestine by a trained physician. The implant secures itself with an anchoring mechanism at the upper portion of the small intestine. Placement is performed as an outpatient procedure that does not require incisions.
Once in place, RESET® conforms to the shape and movement of the intestine and may begin to work immediately by creating a physical barrier between receptors in the intestinal wall and food that has been shown to directly affect key hormone levels.
Non-US Clinical studies have shown that RESET® creates changes in gut hormones that mimic mechanisms similar to Roux-en-Y gastric bypass (RYGB)¹ and reduces cardiovascular risks² and liver fibrosis through positive clinical outcomes.
Clinical data suggests RESET® improves insulin resistance and glycemic control and reduces weight in patients with type 2 diabetes and obesity.¹
· Lower blood sugar levels (HbA1c) ¹ ²
· Increase weight loss and lower BMI ¹ ²
· Reduce cardiovascular risk²
The most commonly reported complications of RESET® are gastrointestinal in nature. They include nausea, vomiting, and upper abdominal pain of mild to moderate severity and are mostly prevalent in the early days and weeks following RESET® placement. Uncommon risks include liver abscess, device-related bleeding, device migration, pancreatitis, or other infections, any of which may result in endoscopic or surgical removal of the device. As with all endoscopic and/or implant procedures, serious injury or death can occur.
Treatment with RESET® may last up to 12 months but should not exceed 12 months. Removal of RESET® is conducted through an endoscopic outpatient procedure under general anesthesia.
¹Diabetes Care, American Diabetes Association journal, May 2018, “Effect of the Duodenal-Jejunal Bypass Liner on Glycemic Control in Patients with Type 2 Diabetes with Obesity: A Meta-analysis with Secondary Analysis on Weight Loss and Hormonal Changes.” Pichamol Jirapinyo et al., Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, MA.
²ADA 76th Scientific Sessions, June 2016, “The Effect of 1-Year’s Endoscopic Proximal Intestinal Exclusion Using EndoBarrier on 10-Year Cardiovascular Risk in Type 2 Diabetes.” Robert E. Ryder et al., Sandwell and West, Birmingham Hospitals NHS Trust.
Morphic Medical is currently enrolling patients for its STEP-1 clinical study of RESET® in the United States. Learn more if you or someone you know are interested in participating in the study and would like to see if you qualify to join.
RESET® is limited by Federal (US) Law to investigational use only and is not for sale in any geography.
