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Today, the US Food and Drug Administration approved the marketing of the EndoRotor system for resection (excision) and removal of necrotic (dead) tissue for patients with walled pancreatic necrosis (WOPN), a potentially fatal condition that can occur weeks after episodes of severe acute pancreatitis. , often requires tissue removal.
“This device has shown its potential to provide a minimally invasive way to remove harmful necrotic pancreatic tissue in patients with walled pancreatic necrosis, which occurs in about 15 percent of patients with severe pancreatitis,” said Dr. Charles Viviano, Ph.D. ., Acting Director of the Office of Reproductive, Gastro-Renal, Urological, General Hospital Devices, and Human Factors at the FDA’s Center for Devices and Radiological Health. “Currently, in order to remove dead tissue from the necrotic cavity of the patient’s pancreas, health care providers need to perform invasive surgery or use other endoscopic tools that are not specifically indicated for the treatment of this condition. With today’s marketing authorization, patients with degenerative pancreatic necrosis now have a new treatment option. “
Pancreatitis occurs when digestive enzymes and inflammation cause cell damage or tissue death. Necrotizing pancreatitis occurs when part of the pancreas dies from inflammation or injury. After a few weeks, the area of necrosis can form a walled cavity and become what is called walled pancreatic necrosis. Dead tissue should be removed if it becomes symptomatic, such as worsening pain, causing an infection that can lead to sepsis, or resulting in bowel obstruction.
The EndoRotor system includes a power console, a foot control, a sample trap, and a disposable catheter, and is used in a procedure called direct endoscopic necrosectomy, which mainly consists of two steps. First, the user creates a portal, usually using a metal stent, between the stomach and the necrotic cavity in the pancreas. This portal contains a standard endoscope – a flexible tube with a light and a camera attached to help view the procedure. Second, the user places the EndoRotor through the working channel of the endoscope to cut and remove necrotized tissue.
The FDA evaluated the safety and efficacy of the EndoRotor system in a study of 30 subjects (23 enrolled in the United States) with walled pancreatic necrosis who were indicated to undergo direct endoscopic necrosectomy. Subjects were treated with the EndoRotor system during the procedure. Subjects often required multiple procedures, a total of 63 direct endoscopic necrosectomies with the EndoRotor system to remove necrotic debris from the pancreatic cavity. This averaged 2.1 proceedings per subject. Clinicians determined how many treatments the subject had based on whether the symptoms – such as infected necrosis, fever, sepsis or pain – persisted after each procedure.
The effectiveness of the device was studied by how well it cleared necrotic tissue from the pancreas of the subjects. The amount of necrotic tissue in the pancreas of each subject was measured during contrast-enhanced computed tomography before the procedure and compared with additional CT examination, endoscopy, or magnetic resonance imaging 14 to 28 days after the last procedure. In subjects who underwent procedures with the EndoRotor system, an average reduction in necrotic tissue of 85% was recorded, with half of the subjects having 98.5% clearance of their necrotic tissue.
In a clinical trial, three subjects experienced serious procedure-related adverse events (10% complication rate). Two of these subjects had gastrointestinal bleeding. A third subject experienced pneumoperitoneum (leakage of air from the pancreatic cavity into the abdominal cavity) and later died after suffering from sepsis and failure of multiple organ systems caused by massive collections of infected pancreatic necrosis.
Other serious adverse events reported in the clinical trial, which are considered to be due to the patient’s underlying condition and are not related to the device or procedure, include haematemesis (vomiting of blood), deep vein thrombosis (blood clots) and pancreatitis.
The EndoRotor system should not be used in patients with known or suspected pancreatic cancer at the discretion of the treating physician. The FDA requires a warning in the box to highlight this important thing. The FDA is aware of the death of a patient (outside the U.S.) from pancreatic cancer three months after removal of necrotic pancreatic tissue by the EndoRotor system. This patient was not diagnosed with pancreatic cancer prior to treatment, although the patient’s outcome is believed to be unrelated to the device or procedure.
The EndoRotor system should only be used in patients following other procedures to drain walled pancreatic necrosis.
The EndoRotor system should not be used in patients with walled necrosis who have a documented pseudoaneurysm (when the vascular wall is injured and when blood leaks into the surrounding tissue) larger than 1 cm inside the cavity or with interventional gastric varices (swollen veins in the stomach) or unavoidable blood vessels within the access tract; or in patients with known or suspected pancreatic cancer.
The FDA has reviewed the EndoRotor system via the De Novo product review pathway, a regulatory pathway for some low- to moderate-risk devices that are new and for which there is no legal market predicate device for which the device may require significant equivalence.
The FDA has approved the marketing of the EndoRotor system to Interscope, Incorporated.
The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines, and other biological products for human use and medical devices. The agency is also responsible for the security and safety of our country’s supply of food, cosmetics, food supplements, products that emit electronic radiation and for the regulation of tobacco products.