First patient at Virginia Commonwealth University (VCU) Medical Center implanted in EndoStim’s LESS GERD clinical trial for gastroesophageal reflux disease (GERD)

RICHMOND and DALLAS, JANUARY 24, 2017 – Virginia Commonwealth University (VCU) Medical Center and EndoStim, Inc., announced that the first patient in Richmond, Virginia has been implanted with the EndoStim device in the Lower Esophageal Sphincter Stimulation for GERD (LESS GERD) trial, at Virginia Commonwealth University (VCU) Medical Center. The EndoStim system is a minimally-invasive implantable device designed to provide long-term reflux control by restoring normal function to the esophagus through neurostimulation.

GERD affects nearly 65 million people in the United States[1]. It occurs when stomach acid or other stomach contents flow back into the esophagus, often caused by a weak valve, or sphincter, between the esophagus and the stomach called the lower esophageal sphincter (LES). Frequent and troublesome symptoms can include heartburn, regurgitation, sleep disruption, vocal impairment and respiratory complications. Most GERD is successfully treated with acid blocking medications such as proton pump inhibitors (PPI). However, nearly 30 percent of patients on PPI medication continue to suffer from symptoms. The traditional anti-reflux surgery is laparoscopic fundoplication surgery, a procedure in which the surgeon wraps the top of the stomach around the lower esophagus to reinforce the lower esophageal sphincter. While typically effective, fundoplication can cause significant side effects.

The LESS GERD trial will evaluate the safety and efficacy of the EndoStim Lower Esophageal Sphincter (LES) Stimulation System in patients with gastroesophageal reflux disease (GERD) who experience symptoms despite taking high-dose proton pump inhibitor (PPI) medications.

Commented Dr. Guilherme M. Campos, MD, FACS, FASMBS, Professor and Chairman of the Division of Bariatric and Gastrointestinal Surgery at VCU and a principal investigator in the study: “GERD disrupts the lives of millions of Americans, and many continue to suffer from symptoms even when taking appropriate medications. Published international data2 suggest that the EndoStim system can be a promising approach to help the population suffering from disruptive GERD symptoms.”

“The LESS GERD clinical trial is a significant undertaking to generate the first randomized, controlled, double blind evidence for a treatment for chronic GERD,” said Rohan Hoare, Ph.D., President and Chief Executive Officer of EndoStim. “We are excited to begin this study in Richmond and look forward to working with the world-renowned team at VCU to establish EndoStim therapy in the United States.”

About the Lower Esophageal Sphincter Stimulation for GERD (LESS GERD) Trial

The LESS GERD trial will examine the effects of the EndoStim LES Stimulation System on GERD outcomes such as: esophageal acid exposure; GERD symptoms (heartburn and regurgitation); ability to avoid dependence on PPI medications; and the effect on overall quality of life. A minimum of 110 subjects will be implanted with the EndoStim device. The study is open to GERD patients who are between the ages of 22 and 75; have been diagnosed with GERD; have taken daily PPI medication and whose GERD symptoms are not completely resolved or have side effects from the PPI; and have had no prior surgery involving the esophagus.

Patients seeking information on the trial should visit: www.lessgerd.com.

About VCU and VCU Health

Virginia Commonwealth University is a major, urban public research university with national and international rankings in sponsored research. Located in downtown Richmond, VCU enrolls more than 31,000 students in 225 degree and certificate programs in the arts, sciences and humanities. Seventy-nine of the programs are unique in Virginia, many of them crossing the disciplines of VCU’s 13 schools and one college. The VCU Health brand represents the health sciences schools of VCU, the VCU Massey Cancer Center and the VCU Health System, which comprises VCU Medical Center (the only academic medical center and Level I trauma center in the region), Community Memorial Hospital, Children’s Hospital of Richmond at VCU, MCV Physicians and Virginia Premier Health Plan. For more, please visit www.vcu.edu and vcuhealth.org 

About EndoStim

EndoStim is a medical device company based in Dallas, Texas, and Nijmegen, The Netherlands, developing and commercializing a revolutionary treatment for GERD. The EndoStim LES Stimulation System is CE Marked for patients with gastroesophageal reflux disease with symptom duration of six months or longer, and is available in a number of countries throughout Europe, Latin America, and Asia Pacific. The EndoStim system is not approved for sale in the US and is limited by US federal law to investigational use only. For more information, visit www.endostim.com.

[1] National Institute of Diabetes and Digestive and Kidney Diseases, Definition and Facts for GER and GERD, http://www.niddk.nih.gov/health-information/health-topics/digestive-diseases/ger-and-gerd-in-adults/Pages/definition-facts.aspx. Accessed June 9, 2016.

2 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 Jul;30(7):2666-72.

PMID: 26487200.

 

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