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Interscope Announces FDA De Novo Marketing Authorization of the EndoRotor® System for Direct Endoscopic Necrosectomy (DEN) - Vimarsana News

Interscope Announces FDA De Novo Marketing Authorization of the EndoRotor® System for Direct Endoscopic Necrosectomy (DEN)

Press release content from PR Newswire. The AP news staff was not involved in its creation. 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. C...

Source: apnews.com
FDA authorizes marketing of new device designed to remove dead pancreatic tissue - Vimarsana News

FDA authorizes marketing of new device designed to remove dead pancreatic tissue

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...

Source: fda.gov