 Agency authorized first device indicated to treat patients with necrotic tissue resulting from complications of acute pancreatitis Today, the U.S. Food and Drug Administration authorized marketing of the EndoRotor System to resect (cut out) and remove necrotic (dead) tissue for patients with walled-off pancreatic necrosis (WOPN), a potentially deadly condition which can occur several weeks after an episode of severe acute pancreatitis, often requiring tissue removal. "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 percent 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. "Currently, in order to remove dead tissue from a patient's necrotic pancreatic cavity, health care providers need to perform an invasive surgery or use other endoscopic tools not specifically indicated to treat this condition. With today's marketing authorization, patients with walled-off pancreatic necrosis now have a new treatment option." Pancreatitis occurs when digestive enzymes and inflammation cause cellular damage or tissue death. Necrotizing pancreatitis occurs when part of the pancreas dies because of inflammation or injury. After several weeks, the area of necrosis may form a walled off cavity and become what is called walled-off pancreatic necrosis. It is necessary to remove the dead tissue if it becomes symptomatic, such as... |
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