Please note that this date is based off of the date that the article was accepted for publication as the event dates were not p provided in the published literature.Concomitant medical products: product id: neu_enterra_ins, lot#: unknown, product type: implantable neurostimulator.Product id: neu_unknown_lead, lot#: unknown, product type: lead.Product id: neu_enterra_ins, lot#: unknown, product type: implantable neurostimulator.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.
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Corvinus, f.M, heinrich, s., neumann, h., neumann, h., hadzijusufovic, e., babic, b., lang, h., grimminger, p.P.Minimal-invasive temporary gastric stimulation: a pilot study to predict the outcome of electronic gastric stimulation with the enterra system.Dig liver dis.2018.Doi: 10.1016/j.Dld.2018.05.023 summary: gastroparesis (gp) is defined as delayed gastric emptying (ge) without any obstruction of the pylorus.It can be divided into idiopathic, diabetic, post surgical and rare causes.Electronic gastricstimulation (egs) ¿ enterra medtronictm¿ is a part of gp therapy.Although its positive impact has been reported in open label trials, randomized controlled trials failed in demonstrating a positive outcome.The aim of this pilot study was to establish a reliable prediction for permanent gastric stimulation.Patients and procedure: 6 female patients underwent laparoscopic implantation of 2 temporary electrodes.The enterratm system was connected and taped to the skin.Baseline and postoperative gastroparesiscardinal symptom index (gcsi), a validated index for gp therapy, was assessed.Response to egs was defined as a 50% decrease of baseline gcsi.Results: 4 of 6 patients responded to temporary egs.3 of 4 responders underwent permanent implantation.1 non-responder received a permanent enterratmat another institution.After a median follow-up time of 9 months the responder group gcsi remained low, whereas the non-responder gcsi had increased.Moreover, the health care system was saved d 30,678.03 by this test stimulation concept.Conclusion: laparoscopic implantation of a temporary egs system predicts the outcome of permanent gastric stimulation and is cost-saving.Reported events: one patient had a dislocation of an electrode after 30 days of stimulation.At that time the patient had already fulfilled the responder criteria of 23 days.No specific device information provided.
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