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Devices designed to make incisions in a papilla, typically the major duodenal papilla. These devices typically consist of a hollow tubular structure (e.g., a cannulating catheter) with an electrosurgical electrode (e.g., cutting wire, needle knife) that protrudes from the distal end. Papillotomes are introduced in the gastrointestinal tract through the working channel of a flexible endoscope (e.g., duodenoscope); a mechanism at the proximal end (handle) can be used to flex the distal tip of the catheter. The cutting wires are made of monofilament or braided wires that are attached at the proximal end of the device to an electrosurgical unit (typically monopolar) that provides circulation of radio-frequency electric current between the active electrode and an external neutral electrode to heat the tissues and facilitate incising and cauterizing the papilla. Papillotomes typically include one or more lumens that permit injection of contrast agents and/or passage of a guide wire. Papillotomes are used mainly for therapeutic and diagnostic procedures involving biliary or pancreatic ducts (e.g., endoscopic pancreatic sphincterotomy, endoscopic retrograde cholangiopancreography, accessing the biliary or pancreatic ductal system).
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