The FDA announced that it authorized the marketing of Interscope’s EndoRotor system for resecting and removing necrotic tissue.
Interscope’s EndoRotor system resects (cuts out) and removes necrotic (dead) tissue for patients with walled-off pancreatic necrosis (WOPN), which can occur several weeks after an episode of severe acute pancreatitis and often requires tissue removal, according to a news release.
The EndoRotor, which received FDA 510(k) clearance for gastroenterology and colorectal surgery in May 2017, features a power console, foot control, specimen trap and single-use catheter. It is used in direct endoscopic necrosectomy in which a user creates a portal between the stomach and necrotic cavity in the pancreas, then places the EndoRotor through the working channel of an endoscope placed through the portal to cut and remove the necrotized tissue.
FDA said it assessed EndoRotor in a 30-subject trial (23 enrolled in the U.S.), treating subjects with walled-off pancreatic necrosis using the EndoRotor. Clinicians determined that subjects undergoing procedures with EndoRotor saw an average of 85% reduction in necrotic tissue amount, with half of the subjects presenting 98.5% clearance of necrotic tissue.
EndoRotor should not be used in patients with known or suspected pancreatic cancer, FDA noted, as the agency is aware of a patient death (outside the U.S.) from pancreatic cancer three months after having necrotic pancreatic tissue removed with the platform.
The system should only be used in patients following other procedures to drain the walled-off pancreatic necrosis, the FDA added.