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Worcester startup gets European medical device approval
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FDA authorizes marketing of EndoRotor system
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FDA Clears Device to Remove Dead Pancreatic Tissue
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Interscope Announces FDA De Novo Marketing Authorization of the EndoRotor® System for Direct Endoscopic Necrosectomy (DEN)
December 24, 2020 GMT
NORTHBRIDGE, Mass., Dec. 24, 2020 /PRNewswire/ Interscope, Inc. announced today the receipt of FDA de novo clearance to market its EndoRotor® System in the United States for direct endoscopic necrosectomy (DEN), a minimally invasive treatment for walled-off pancreatic necrosis. The EndoRotor System received CE Mark in Europe for this indication in 2018.
Current clinical data demonstrates the migration from surgical necrosectomy to DEN. While DEN is a safer approach, it involves the use of conventional instruments such as polypectomy snares and biopsy forceps, which are not specifically indicated or cleared for DEN. Therapeutic use of these devices requires an average of four (4) procedures in order to clear the necrosis and is associated with
December 23, 2020
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 sp