The FDA today issued a final order lowering the risk classification for pancreatic drainage stents at the request of device maker Xlumena.
The FDA agreed that Class II special controls are sufficient to ensure that new devices are safe and effective, taking pancreatic stents off of the more-stringent premarket approval system.
Xlumena requested the downgrade in February 2013, asking regulators to ease regulation for its AXIOS stent and delivery system, according to an FDA memo. Pancreatic stents were originally placed into the more regulated Class III category by default, having been introduced into the market after May 28, 1976, when the Medical Device Amendments of 1976 were established.
The FDA issued reviewed Xlumena’s request and issued a reclassification proposal concurrent with granting premarket approval for the company’s Axios device. The FDA finalized the downgrade order this week.
Xlumena’s stent was the 1st of its kind, specifically designed for the drainage of a pancreatic pseudocyst by creating a new, temporary opening between the pancreas and the gastrointestinal tract.