FDA allows marketing of new stent for treating pseudocysts of the pancreas
Although most people associate the pancreas with the production of insulin to regulate blood sugar and the part it plays in whether or not someone may develop diabetes, the organ located in the upper abdominal area behind the stomach also produces numerous enzymes vital to the digestion of carbohydrates, fats, and proteins, and contains a duct system that feeds into one larger duct that drains enzymes into thr duodenum (part of the small intestine) where the enzymes are combined with food to provide for normal digestion.
These ducts, however, can (at times) become blocked from gallstones or after an injury to the pancreas, causing the enzymes that normally drain into the small intestine to be released directly into the pancreas, which, in turn my result in the devlopment of pseudocysts to form. While the majority of psuedocysts are generally small enough to disolve on theit own, some can grow as large as 7 centimeters, which can become infected by bacteria, and lead to serious blood infections that can be life-threatening. They are also extremely painful.
“Pancreatic stents currently on the market are indicated for pancreatic drainage and are to be placed through the pancreas’ existing ducts, but this frequently does not provide adequate drainage of a pseudocyst,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.
As a result, the FDA has now approved the sale of the AXIOS Stent and Delivery System (a wire mesh tube with a silicone covering) specifically designed to create a temporary opening between the pancreas and and the gastrointestinal tract to allow the pseudeocysts to drain, “with a less invasive intervention than surgical removal of the pseudocyst.”
The stent is tightly compressed inside a catheter that is inserted into the stomach through an endoscope that is passed through the patient’s mouth and down into an area of the stomach adjacent to the pseudocyst. After creating a small opening in the wall of the stomach and a small opening in the pseudocyst, the surgeon positions the still-compressed stent across both openings, releases the stent and removes the delivery system. Once expanded, the stent allows the contents of the pseudocyst to drain into the stomach. Once the pseudocyst has drained and decreased in size the AXIOS Stent can be removed with standard endoscopic tools.
To learn more physicians and patients can contact the FDA at 888-INFO-FDA