EndoStim Electrical Stimulation Therapy is a form of anti-reflux

surgery Surgery is a medical specialty that uses manual and instrumental techniques to diagnose or treat pathological conditions (e.g., trauma, disease, injury, malignancy), to alter bodily functions (e.g., malabsorption created by bariatric surgery s ...

, intended to assist in correcting a problem with the muscles at the bottom of the

esophagus The esophagus (American English), oesophagus (British English), or œsophagus (Œ, archaic spelling) (American and British English spelling differences#ae and oe, see spelling difference) all ; : ((o)e)(œ)sophagi or ((o)e)(œ)sophaguses), c ...

(the tube from the mouth to the stomach). Problems with these muscles allow

gastroesophageal reflux disease Gastroesophageal reflux disease (GERD) or gastro-oesophageal reflux disease (GORD) is a chronic upper gastrointestinal disease in which stomach content persistently and regularly flows up into the esophagus, resulting in symptoms and/or ...

(GERD) to happen. The procedure was developed by Endostim, based in

St. Louis St. Louis ( , sometimes referred to as St. Louis City, Saint Louis or STL) is an independent city in the U.S. state of Missouri. It lies near the confluence of the Mississippi and the Missouri rivers. In 2020, the city proper had a populatio ...

Missouri Missouri (''see #Etymology and pronunciation, pronunciation'') is a U.S. state, state in the Midwestern United States, Midwestern region of the United States. Ranking List of U.S. states and territories by area, 21st in land area, it border ...

, and

Amsterdam Amsterdam ( , ; ; ) is the capital of the Netherlands, capital and Municipalities of the Netherlands, largest city of the Kingdom of the Netherlands. It has a population of 933,680 in June 2024 within the city proper, 1,457,018 in the City Re ...

Netherlands , Terminology of the Low Countries, informally Holland, is a country in Northwestern Europe, with Caribbean Netherlands, overseas territories in the Caribbean. It is the largest of the four constituent countries of the Kingdom of the Nether ...

. __TOC__

Technique

EndoStim therapy directly targets the weak

lower esophageal sphincter The esophagus (American English), oesophagus (British English), or œsophagus ( archaic spelling) ( see spelling difference) all ; : ((o)e)(œ)sophagi or ((o)e)(œ)sophaguses), colloquially known also as the food pipe, food tube, or gullet, ...

(LES) muscle, without altering anatomy or using mechanical constraints. EndoStim's proprietary technology uses

functional electrical stimulation Functional electrical stimulation (FES) is a technique that uses low-energy electrical pulses to artificially generate body movements in individuals who have been paralyzed due to injury to the central nervous system. More specifically, FES ca ...

(a type of

neuromodulation Neuromodulation is the physiological process by which a given neuron uses one or more chemicals to regulate diverse populations of neurons. Neuromodulators typically bind to metabotropic, G-protein coupled receptors (GPCRs) to initiate a sec ...

) to restore esophageal function, thereby reducing GERD symptoms. Tiny pulses of electric current are delivered to the LES without causing any sensation. The implantable pulse generator (IPG) and bipolar lead deliver therapy to the lower esophageal sphincter. The IPG is a small device similar to a

pacemaker A pacemaker, also known as an artificial cardiac pacemaker, is an implanted medical device that generates electrical pulses delivered by electrodes to one or more of the chambers of the heart. Each pulse causes the targeted chamber(s) to co ...

and is implanted under the skin of the

abdomen The abdomen (colloquially called the gut, belly, tummy, midriff, tucky, or stomach) is the front part of the torso between the thorax (chest) and pelvis in humans and in other vertebrates. The area occupied by the abdomen is called the abdominal ...

. The lead connects two electrodes from the IPG to the esophagus. Both the IPG and lead are placed laparoscopically through a short,

minimally-invasive procedure Minimally invasive procedures (also known as minimally invasive surgeries) encompass surgical techniques that limit the size of incisions needed, thereby reducing wound healing time, associated pain, and risk of infection. Surgery by definition ...

under

general anesthesia General anaesthesia (UK) or general anesthesia (US) is medically induced loss of consciousness that renders a patient unarousable even by painful stimuli. It is achieved through medications, which can be injected or inhaled, often with an analgesi ...

. The

implant Implant can refer to: Medicine *Implant (medicine), or specifically: **Brain implant **Breast implant **Buttock augmentation, Buttock implant **Cochlear implant **Contraceptive implant **Dental implant **Fetal tissue implant **Implantable cardiov ...

ation procedure lasts approximately 40 minutes, and involves attaching two small electrodes from the lead to the lower esophagus. The lead is brought out into a small pocket located under the abdominal skin and connected to the stimulation device (IPG). Minimally-invasive procedures have been shown to dramatically reduce healing time as well as reduce procedure risk. The first

clinical study Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...

using EndoStim technology was published in 2010, showing that in patients with GERD, electrical stimulation therapy significantly and consistently increased LES pressure. An

open-label trial An open-label trial, or open trial, is a type of clinical trial in which information is not withheld from trial participants. In particular, both the researchers and participants know which treatment is being administered. This contrasts with a d ...

conducted in Chile showed the procedure showed “significant and sustained improvement in GERD symptoms, esophageal pH, and reduction in

proton-pump inhibitor Proton-pump inhibitors (PPIs) are a class of medications that cause a profound and prolonged reduction of gastric acid, stomach acid production. They do so by irreversibly inhibiting the stomach's H+/K+ ATPase, H+/K+ ATPase proton pump. The body ...

(PPI) usage without any side effects” in patients.

Usage

Endostim therapy is currently not approved by the U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

(FDA). The procedure, however, received the

CE mark The presence of the logo on Product (business), commercial products indicates that the Manufacturing, manufacturer or importer affirms the goods' conformity with European Environment, health and safety, health, safety, and environmental prote ...

allowing implants in Europe. Endostim is carried out in Argentina, Chile, Colombia, Brazil, Hong Kong, India, Denmark, Germany, Netherlands and Switzerland.

References

{{reflist Digestive system procedures