FDA Authorizes Necrotic Tissue Removal Device
The FDA has granted De Novo marketing authorization for Interscope’s EndoRotor system, a device designed to remove tissue from patients with walled-off pancreatic necrosis (WOPN).
The minimally invasive system removes dead tissue from patients with WOPN, a potentially serious condition that can occur several weeks after an episode of severe acute pancreatitis. The dead tissue must be removed because it can obstruct the intestines or cause an infection that leads to sepsis.
The system, which received CE mark certification for the same indication in 2018, includes a power console, foot control, specimen trap and single-use catheter.