SetPoint Medical implant studymodulates the inflammatory reflex via vagus nerve to treat Crohn's Disease.
SetPoint Medical, presented positive results from an ongoing study modulating the inflammatory reflex to treat Crohn's Disease (CD), a debilitating disease caused by inflammation in the digestive tract. The data were presented at United European Gastroenterology Week (UEGW) in Vienna.
In this study, eight patients with severe Crohn's Disease not responsive to TNF antagonists received an implant on the vagus nerve in their neck to deliver digital doses to the vagus nerve. Improvement was assessed at the sixteen-week mark using the primary endpoint for the study a change from baseline to week 16 in the Crohn's Disease Activity Index (CDAI), a tool used to quantify the symptoms of patients with the disease. Severe Crohn's is defined by a CDAI greater than 450, and remission is defined as a CDAI below 150.
At the primary end point, the CDAI scores of six of the eight patients in the study were reduced by 70 points or more, and CDAI remission and endoscopic remission was achieved in three patients. The data also show a direct correlation between vagus nerve stimulation and the suppression of pro-inflammatory cytokines, including TNF, which plays a key role in inflammation, a finding consistent with the results from the company's earlier study in patients with rheumatoid arthritis.
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