FDA Authorizes New Device To Remove Necrotic Pancreatic Tissue
The U.S. Food and Drug Administration on December 23 authorized marketing of the EndoRotor System, designed to resect and remove necrotic tissue among patients with walled-off pancreatic necrosis (WOPN), a condition that most often occurs within 4 weeks of an episode of acute pancreatitis.
“This device has shown its potential to provide a minimally invasive way to remove harmful necrotic pancreatic tissue in patients with walled-off pancreatic necrosis, which occurs in about 15% of patients with severe pancreatitis,” said Charles Viviano, M.D., Ph.D., acting director of the Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office in the FDA’s Center for Devices and Radiological Health, in a statement released by the agency.
Necrotizing pancreatitis occurs when inflammation or trauma results in the death of pancreatic tissue. Over the course of several weeks, the necrotic tissue may become encapsulated. WOPN, formerly called pancreatic abscess, may cause infection leading to sepsis or result in intestinal obstructions. Without treatment, WOPN can be fatal.
To date, removing necrotic pancreatic tissue has required invasive surgery or the use of endoscopic tools that were not indicated for this purpose. The EndoRotor System enables direct endoscopic necrosectomy. The system first creates a portal between the stomach and the necrotic pancreatic tissue. The EndoRotor is inserted through a standard endoscope into the portal, where the necrotic tissue can be cut and removed.
In a clinical trial of 30 patients with WOPN, an average of 2.1 procedures per patient were needed to fully remove necrotic tissue from the pancreatic cavity. The trial demonstrated an average reduction in necrotic tissue of 85%; half of the patients experienced a 98.5% clearance of necrotic pancreatic tissue.
Three patients in the trial experienced procedure-related serious adverse events; 1 patient died due to sepsis.
The FDA is requiring a boxed warning indicating that the EndoRotor System should not be used in patients with known or suspected pancreatic cancer. The agency stated that it is “aware of a patient death (outside of the U.S.) from pancreatic cancer three months after having necrotic pancreatic tissue removed with the EndoRotor System. This patient did not have a diagnosis of pancreatic cancer prior to treatment, although the patient’s outcome is believed to be unrelated to the device or procedure.”
The system should only be used in patients following other procedures to drain the walled-off pancreatic necrosis, the FDA further stated, and should not be used in patients with a documented pseudoaneurysm greater than 1 cm within the cavity or with intervening gastric varices or unavoidable blood vessels within the access tract.
The FDA reviewed the EndoRotor System through the De Novo premarket review pathway, which the agency uses to clear some devices it considers to present low to moderate risk and for which no predicate device being legally marketed can claim substantial equivalence.
Reference: FDA authorizes marketing of new device designed to remove dead pancreatic tissue. News release. U.S. Food and Drug Administration. December 23, 2020. Accessed December 29, 2020. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-new-device-designed-remove-dead-pancreatic-tissue