BIEFFE CLEAN - medical device

BIEFFE CLEAN is a class IIa medical device containing macrogol and electrolytes. PRODUCT The product is intended for bowel preparation for diagnostic tests. It can be used to clean the bowel before a colonoscopy or to promote the distension of the intestinal loops before a CT enterography or an MR enterography. INNOVATIVE FEATURES BIEFFE CLEAN Plus action is purely mechanical and takes place in the bowel. It is due to macrogol, a polymer of ethylene glycol, which is inert and therefore is not absorbed orfermented by the flora resident in the digestive tract. Macrogol can bind the water used for intake maintaining it within the intestinal lumen and, depending upon the methods of use and the volumes foreseen, can act as a catharticor a hypodense contrast medium. The macrogol intended for preparation for colonoscopy is dosed and administered in order to induce the formation of loose stools and thus guarantee the complete removal of faecal residues from colon: it can be used at high volume, alone, or at low volume, normally in combination with an additional laxative. Another possibility of using macrogol at low volume concerns the execution of diagnostic investigations such as CT enterography or MR enterography: in this case, the preparation favours the retention of the contrast solution in the small intestine, allowing it to keep the distensionof the loops for a sufficient time in order to acquire the images.