Obesity and diabetes is a growing problem around the world. WHO estimates that in 2015, >13% of the population or >600million were obese. About 200million or ~30% of this obese population has Type 2 Diabetes Mellitus (T2DM). Roux-en-Y gastric bypass surgery is currently the gold standard in bariatric surgery, with long-term data demonstrating the ability to manage obesity and diabetes. Despite its efficacy, patient adoption has been low, <1% of the eligible population. Patients are reluctant to undergo a highly invasive, irreversible surgical alteration of their anatomy, with potential long-term risks of malabsorption.
The Allevetix™ is an endoscopically delivered and retrieved device that comprises of an isolating duodenal sleeve and a dual-purpose gastric balloon. The duodenal sleeve prevents absorption of food in the duodenum and proximal jejunum, while the gastric balloon anchor prevents distal migration and, additionally enhances satiety by occupying space in the stomach.
The team has developed the prototype and are currently in the phase of pre-clinical lab and animal testing according to EU MDD and ISO13485 requirements.
Refinement of prototype towards design freeze phase addressing risk assessment and manufacturability aspects complying with ISO13485 requirements, followed by carrying out animal trials.
Principal Investigator: Dr Asim SHABBIR
Institution: National University Health System
NHIC Ref: NHIC-I2D-1604109