Marketing authorized for new device that removes dead pancreatic tissue

The FDA recently authorized marketing of a new device designed to remove dead pancreatic tissue.

The EndoRotor System is the first device indicated to treat patients with walled-off pancreatic necrosis resulting from complications of acute pancreatitis, the FDA said in a Dec. 23 news release. In a trial of 30 participants with walled-off pancreatic necrosis who were indicated to undergo a direct endoscopic necrosectomy with the system, there was an average of 85% reduction in the amount of necrotic tissue, with half of the subjects having 98.5% clearance of their necrotic tissue.

On average, participants required about two procedures each. In the trial, three participants experienced procedure-related serious adverse events (two had GI bleeding, while the third experienced a pneumoperitoneum and later died). Other serious adverse events included hematemesis, deep venous thrombosis, and pancreatitis. The system should not be used in patients with known or suspected pancreatic cancer, and a boxed warning will emphasize this point, the FDA said.