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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 a complication rate of approximately 22%.1 The EndoRotor System allows a physician to simultaneously resect and aspirate necrotic material from a walled-off pancreatic collection under direct endoscopic visualization through a lumen apposing metal stent or cystogastrostomy. The recently completed FDA Investigational Device Exemption (IDE), which enrolled 30 patients in the United States and Europe, demonstrated an average of two (2) procedures to complete necrosectomy, no complications related to the use of EndoRotor, and a 10% procedural complication rate. Furthermore, trial patients were hospitalized for an average of sixteen (16) days as compared to an average of 32 days reported in literature.1-3