First patient at Allegheny Health Network implanted in EndoStim’s LESS GERD clinical trial for gastroesophageal reflux disease (GERD)
PITTSBURGH, PA and DALLAS, TX APRIL 19, 2017– The Esophageal and Lung Institute of Allegheny Health Network and EndoStim, Inc., announced that the first patient in Pittsburgh, PA has been implanted with the EndoStim device in the Lower Esophageal Sphincter Stimulation for GERD (LESS GERD) trial, at West Penn Hospital. 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. It occurs when stomach acid or other stomach contents flow back into 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 gastro-esophageal reflux disease (GERD) who experience symptoms despite taking high-dose proton pump inhibitor (PPI) medications.
“GERD disrupts the lives of millions of Americans, and many continue to suffer from symptoms like heartburn and regurgitation even when taking PPI medications. The EndoStim clinical trial offers a unique treatment option to patients with GERD who meet certain study inclusion criteria,” commented Dr. Blair Jobe, Director of the Esophageal and Lung Institute and a principal investigator in the study.
“We are excited to start the LESS GERD Clinical trial at Allegheny Health Network to generate evidence for a novel new treatment for Chronic GERD, an under treated disease that is disrupting the lives of millions of patients worldwide,” said Rohan Hoare, Ph.D., President and Chief Executive Officer of EndoStim. “Unlike many common treatment options that work to alleviate GERD symptoms, EndoStim targets the underlying pathophysiology of GERD with the potential to restore normal function to the lower esophageal sphincter (LES).”
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 nationally. 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 the Allegheny Health Network:
Allegheny Health Network (AHN.ORG), part of Highmark Health, is an integrated healthcare delivery system serving the Western Pennsylvania region. The Network is comprised of eight hospitals, including its flagship academic medical center Allegheny General Hospital, Allegheny Valley Hospital, Canonsburg Hospital, Forbes Hospital, Jefferson Hospital, Saint Vincent Hospital, Westfield Memorial Hospital and West Penn Hospital; an employed physician organization, a research institute, health + wellness pavilions, home and community-based health services and a group purchasing organization. The Network employs approximately 17,500 people, and has more than 2,100 physicians on its medical staff. The Network also serves as a clinical campus for Temple University School of Medicine, Drexel University College of Medicine and the Lake Erie College of Osteopathic Medicine.
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.
 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.