Clinical Evidence

EndoStim Clinical Evidence

Long-term clinical results of EndoStim patients treated for up to five years shows that LES stimulation is safe and effective in controlling GERD symptoms and improving patient quality of life in most patients.

Most patients experience:

  • Resolution of regurgitation and heartburn
  • Significant improvement in sleep issues related to reflux
  • Elimination of dependency on PPI medication
  • Long-term normalization of acid exposure and sphincter function

 

International clinical results:

Meta-analysis of 2 published trials: Significant improvement in GERD symptoms and esophageal pH

 

Sustained improvement in GERD outcomes (GERD-HRQL)
Sustained improvement in esophageal acid exposure


 
Outcomes from ongoing multicenter commercial patient registry confirm results of the 2 long-term studies
Sustained improvement in GERD outcomes (GERD-HRQL)
Sustained improvement in esophageal acid exposure


 

Selected Publications

 

Electrical lower esophageal sphincter augmentation in patients with GERD and severe ineffective esophageal motility –a safety and efficacy study. Paireder, M., Kristo, I., Asari, R. et al. Surg Endosc (2019). https://doi.org/10.1007/s00464-018-06649-y

Electrial Stimulation of the Lower Esophageal Sphincter in Patients with Gastroesophageal Reflux Disease and Impaired Esphageal Motility Matthias Paireder, Ivan Kristo, Erwin Rieder, Kathrin Schwameis, Johannes Steindl, Sebastian F. Schoppmann, FACS Diseases of the Esophagus, Volume 31, Issue 13, 1 September 2018, Pages 66,https://doi.org/10.1093/dote/doy089.PS01.056

EndoStim®-treatment – a new minimaly invasive technology in antireflux surgery Stephan, D., Attwood, S., Labenz, J. et al. Der Chirurg 2018; 104: S1-8. https://doi.org/10.1007/s00104-018-0706-2

Alternative therapies for GERD- a way to personalized antireflux surgery. Rieder E, Rieder M, Simic A, et al. Annals of the New York Academy of Sciences. 2018; Global Perspectives on Esophageal Diseases [special issue]: S1-10. https://nyaspubs.onlinelibrary.wiley.com/doi/epdf/10.1111/nyas.13851  

Electrical lower esophageal sphincter augmentation in patients with GERD and severe ineffective esophageal motility –a safety and efficacy study. Paireder, M., Kristo, I., Asari, R. et al. Surg Endosc (2019). https://doi.org/10.1007/s00464-018-06649-y

Interim Results of a Prospective Multi-Center Registry of Lower Esophageal Sphincter Stimulation for Gerd: The Lessgerd Registry. Labenz Joachim Labenz, Pravin Thattamparambil, Carsten Gutt, Alejandro Nieponice, Vivianda Menke, Ahmed Madisch, Ralf Weise, Sebastian F. Schoppmann, Jan B. Pedersen, Ernst P. Eypasch, Frank Benedix, Nicole D. Bouvy, Norbert Hesselbarth; Gastroenterology 2018 https://doi.org/10.1016/S0016-5085(18)30777-7

 

Electrical stimulation of the lower esophageal sphincter to address gastroesophageal reflux disease after sleeve gastrectomy. Borbély Y, M.D., F.A.C.S., et al. Surgery for Obesity and Related Diseases. 2018; 14 (5): S611–615 https://doi.org/10.1016/j.soard.2018.02.006

Electrical Stimulation of the Lower Esophageal Sphincter to Treat Gastroesophageal Reflux After POEM. Erwin Rieder, Matthias Pairede, Ivan Kristo,Katrin Schwameis, Sebastian F. Schoppmann; SAGES Journal 2018 https://doi.org/10.1177/1553350618768129

Madisch A. Elektrische Stimulation des unteren Ösophagussphinkters zur Therapie der GERD: Internationale prospektive Registerstudie (LESS-GERD Registry): Registerstudie  Labenz J, Schulz H, Leodolter A, Pedersen JP, Nieponice A, Weise R, Bouvy N, Gutt C, Schoppmann S, Madisch A. Z Gastroenterol. 2017; 55:e72 https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0037-1604750

Laparoskopische Implantation eines Stimulationssystems für den unteren Ösophagussphinkter bei Refluxerkrankung– Erfahrungen eines interdisziplinären Refluxzentrums: Keine Studie, Erfahrungsbericht Stephan D, Labenz J, Labenz G,Borkenstein DP, Willeke F. Z Gastroenterol. 2017; 55:e73. https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0037-1604753

Preliminary results of a prospective multicenter registry of lower esophageal sphincter stimulation for GERD: The LESS-GERD Registry:Registerstudie Labenz J, Schulz HG, Leodolter A, Pedersen JB, Nieponice A, Weise R, Bouvy ND. Gastroenterology. 2017; 152(5):S470. http://www.gastrojournal.org/article/S0016-5085(17)31765-1/abstract

Electrical stimulation therapy (EST) of the lower esophageal sphincter (LES) for refractory GERD and two year results of an international multicenter trial. Siersema PD, Bredenoord AJ, Conchillo JM, Ruurda J, van Berge Henegouwen M, Chiu P, Booth M, Hani AC, Bogte A, Smout AJ, Wu JC, Escalona A, Valdovinos MA, Torres-Villalobos G, Kappelle W, Botha A, Bouvy ND. Gastroenterology. 2017; 152(5):S470. https://doi.org/10.1016/S0016-5085(17)31766-3

Electrical stimulation of the lower esophageal sphincter (LES) improves gastroesophageal reflux disease (GERD) in patients with laparoscopic sleeve gastrectomy (LSG): nicht-randomisierte Interventionsstudie Borbély YM, Nieponice A, Rodriguez LA, Schulz HG, Ortiz C, Talbot M, Martin D, Bouvy ND. Gastroenterology. 2017; 152(5):S1286 http://www.gastrojournal.org/article/S0016-5085(17)34287-7/fulltext

Interim results of a prospective multicenter registry of lower esophageal sphincter stimulation for GERD. Labenz J, Schulz H, Leodolter A, Pedersen J, Nieponice A, Weise R, Bouvy N. Surg Endosc. 2017; 31:S14.

EndoStim® LES Stimulation Therapy Improves GERD in Patients with Laparoscopic Sleeve Gastrectomy (LSG). Borbely Y, Nieponice A, Rodriguez L, Schulz H, Ortiz C, Talbot M, Martin D, Bouvy N. UEG Journal. 2016; 4(5S):A24.

Electrical Stimulation of the LES – An Emerging Therapy for GERD Patients with Failed Esophageal Peristalsis: nicht-randomisierte Interventionsstudie Ramirez M, Zubieta C, Ciotola F, Bilder C, Ditaranto A, Badaloni A, Nieponice A. UEG Journal. 2016; 4(5S):A24. https://www.sages.org/meetings/annual-meeting/abstracts-archive/electrical-stimulation-of-the-les-an-emerging-therapy-for-gerd-patients-with-failed-esophageal-persitalsis/

Preliminary Results of a Prospective Multi-center Registry of Lower Esophageal Sphincter Stimulation for GERD: The LESS-GERD Registry: Registerstudie Labenz J, Schulz H, Leodolter A, Pedersen J, Nieponice A, Weise R, Bouvy N. UEG Journal. 2016; 4(5S):A128. http://www.gastrojournal.org/article/S0016-5085(16)31647-X/abstract

Electrical Stimulation Therapy of the Lower Esophageal Sphincter in Treating Gastroesophageal Reflux Disease in Children, Open Label Prospective Trial: Keine Studie Erfahrungsberich Rodrigo Hipolito Cifuentes UEG Journal. 2016; 4(5S):A239 https://pediatriccongress.conferenceseries.com/abstract/2017/electrical-stimulation-therapy-of-the-lower-esophageal-sphincter-in-treating-gastro-esophageal-reflux-disease-in-children-open-label-prospective-trial

Electrical Stimulation Therapy (EST) of the Lower Esophageal Sphincter (LES) for Refractory GERD – One Year Results of an International Multicenter Trial: nicht-randomisierte Interventionsstudie Siersema PD, Bredenoord AJ, Conchillo JM, Hani AC, Booth M, Escalona A, Botha A, Wu JC, Reddy ND, Torres-Villalobos G, Chiu PW, Bouvy ND, van Berge Henegouwen MI, Ruurda JP, Quezada N, Valdovinos MA. Gastroenterology . 2016; 150(4): S216. http://www.gastrojournal.org/article/S0016-5085(16)30800-9/abstract

Effect of Electrical Stimulation Therapy of the Lower Esophageal Sphincter on Postprandial Reflux Mechanisms in GERD Patients: nicht-randomisierte Interventionsstudie Rinsma NF, Kessing BF, Bouvy ND, van Berge Henegouwen MI, Smout AJ, Bredenoord AJ, Masclee A, Conchillo JM. Gastroenterology. 2016;150(4):S478. http://www.gastrojournal.org/article/S0016-5085(16)31646-8/abstract

Electrical Stimulation Therapy (EST) of the Lower Esophageal Sphincter (LES) is Successful in Treating GERD – Long-term 4 Year Results: Multicenter-Registerstudie Prospektive Beobachtungsstudie Rodriguez L, Rodriguez P, Gomez B, Galvao Neto M, Crowell M, Soffer E. Gastroenterology. 2016; 150(4):S476. http://www.gastrojournal.org/article/S0016-5085(16)31639-0/fulltext

Preliminary Results of a Prospective Multi-Center Observational Registry of Lower Esophageal Sphincter Stimulation for GERD: The Less- GERD Registry: Registerstudie Labenz J, Schulz HG, Leodolter A, Pedersen JB, Eypasch E, Nieponice A, Weise R, Bouvy ND. Gastroenterology. 2016;150(4):S478. http://www.gastrojournal.org/article/S0016-5085(16)31647-X/abstract

Electrical Stimulation Therapy (EST) of the Lower Esophageal Sphincter (LES) is Successful in Treating GERD – Long-term 4 Year Results: Multicenter-Registerstudie Prospektive Beobachtungsstudie Rodriguez L, Rodriguez P, Gomez B, Galvao Neto M, Crowell M, Soffer E. Gastroenterology. 2016; 150(4):S476. http://www.gastrojournal.org/article/S0016-5085(16)31639-0/fulltext 

Preliminary Results of a Prospective Multi-Center Observational Registry of Lower Esophageal Sphincter Stimulation for GERD: The Less- GERD Registry: Registerstudie Labenz J, Schulz HG, Leodolter A, Pedersen JB, Eypasch E, Nieponice A, Weise R, Bouvy ND. Gastroenterology. 2016;150(4):S478. http://www.gastrojournal.org/article/S0016-5085(16)31647-X/abstract

EndoStim LES Stimulation Therapy Improves GERD in Patients with Laparoscopic Sleeve Gastrectomy (LSG): nicht-randomisierte Interventionsstudie Nieponice A, Borbely Y, Rodriguez L, Schulz HG, Ortiz C, Talbot M, Martin D, Bouvy N. Surg Endosc. 2016; 30:S263. https://www.sages.org/meetings/annual-meeting/abstracts-archive/endostimr-les-stimulation-therapy-improves-gerd-in-patients-with-laparoscopic-sleeve-gastrectomy-lsg/

Effect of electrical stimulation of the lower esophageal sphincter in gastroesophageal reflux disease patients refractory to proton pump: nicht-randomisierte Interventionsstudie Soffer E, Rodriguez L, Rodriguez P, Gomez B, Neto MG, Crowell MD. World J Gastrointest Pharmacol Ther. 2016;7(1): 145-155. https://www.ncbi.nlm.nih.gov/pubmed/26855821

Electrical stimulation of the lower esophageal sphincter (LES) improves gastroesophageal reflux disease (GERD) in patients with laparoscopic sleeve gastrectomy (LSG): nicht-randomisierte Interventionsstudie Borbély YM, Nieponice A, Rodriguez LA, Schulz HG, Ortiz C, Talbot M, Martin D, Bouvy ND. Gastroenterology. 2017; 152(5):S1286 http://www.gastrojournal.org/article/S0016-5085(17)34287-7/fulltext

Electrical stimulation for gastroesophageal reflux disease: current state of the art: Review (mit zusammengefassten Ergebnissen aus den anderen einzelnen genannten Studien)Kim SE, Soffer E. Clin Exp Gastroenterol. 2016; 9:11-19. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4716744/

Electrical stimulation therapy of the lower esophageal sphincter is successful in treating GERD: long-term 3 year results. Rodriguez L, Rodriguez P, Gómez B, Netto M, Crowell M, Soffer E. Surg Endosc. 2016; 30(7):2666-72 https://www.ncbi.nlm.nih.gov/pubmed/26487200