The FDA said today it is reclassifying Boston Scientific‘s (NYSE:BSX) WallFlex Biliary RX fully covered stent system to a Class II device.
The Marlborough, Mass.-based company submitted a request for reclassification on August 27 last year, according to the FDA release.
The federal watchdog said it reviewed the request and determined the device viable to be classified as a Class II device with the establishment of “special controls,” which in addition to general controls will “provide reasonable assurance of the safety and effectiveness of the device.”
Because the metallic biliary stent system for benign strictures was reclassified, the FDA said that any firm submitting a 510(k) application for such a device will need to comply with the special controls.
The agency said it will require biocampatibility evaluation to avoid adverse tissue reactions, sterilization and shelf-life validation to avoid infection risks, clinical and non-clinical performance and shelf life testing to avoid bile duct obstruction, stent migration and issues with the stent not resolving the obstruction, according to an FDA release.
Clinical and non-clinical performance testing, as well as shelf-life validations will also be required by the FDA to eliminate the risk of trauma to bile ducts during stent deployment and removal.
In September, 2014, Boston Scientific released results from its WallFlex Biliary RX Stent study, touting perfect success in removing the device up to a year following implant.
The devices, used to prop open biliary strictures and provide drainage during surgery, also resulted in relatively low rates of re-stenting following removal.
About 75% of patients did not need another stent at the time that WallFlex was removed, according to a press release. Of those patients, about 85% remained stricture-free after an average of 20 months.
