THE HAGUE, Netherlands and ST. LOUIS, Feb. 19, 2013 /PRNewswire/ -- EndoStim® reports successful results in a patient with severe obesity and severe acid reflux with percent 24-hour distal esophageal acid exposure of 24% (normal defined as <4%). The patient underwent the EndoStim® procedure and began LES stimulation treatment for his GERD in December 2010, showing sustained normalization in his esophageal acid exposure after 12 months of treatment with percent 24-hour distal esophageal acid exposure at 1 year follow-up of 2.4%. He then opted to undergo a sleeve gastrectomy for his severe obesity (weight=108kg; BMI=34.9). After the sleeve gastrectomy procedure, the patient continued using EndoStim LES stimulation treatment to control his reflux. At his 2 year follow-up, he had lost 29kg (weight=79 kg, BMI=25.5) and continued to show excellent control of his acid reflux with percent 24-hour distal esophageal acid exposure at 2 year of 0%.
EndoStim therapy is a minimally-invasive treatment for GERD, designed to use low energy electrical pulses to strengthen a weak or dysfunctional lower esophageal sphincter (LES) muscle – often the underlying cause of GERD.
Preexisting GERD has been a contraindication for sleeve gastrectomy, a minimally-invasive weight loss procedure that is gaining significant popularity globally.
Dr. Leonardo Rodriguez, the treating surgeon at Clinica Indisa, stated, "This is encouraging early proof-of-concept evidence that patients with both severe obesity and GERD can be successfully treated with a combination of a sleeve gastrectomy procedure and EndoStim® LES stimulation therapy. Additionally, many patients will develop severe reflux after a sleeve procedure and cannot undergo fundoplication. EndoStim could be an excellent option for these patients."
"If these results can be replicated in a larger group of patients, this would open up sleeve gastrectomy to millions of obese GERD sufferers that have been denied the benefits of this procedure due to concerns of worsening reflux," commented Dr. Roger de la Torre, world renowned bariatric surgeon at the University of Missouri and Chair of EndoStim's surgical advisors.
Dr. Virender K Sharma, Chief Medical Officer of EndoStim, says, "Acid reflux is a significant problem in sleeve gastrectomy patients. This first case of a successful and safe sleeve gastrectomy procedure combined with EndoStim® LES stimulation therapy is an important step, though further investigation is needed to demonstrate the effect of LES Stimulation in this patient population." The EndoStim System has not been formally evaluated in patients with a history of previous esophogastric surgery.
About Reflux Disease and Sleeve Gastrectomy
Gastroesophageal reflux disease is a chronic disease that affects hundreds of millions of patients worldwide, and often requires lifelong treatment with acid blocker medications. Symptoms generally occur when the weakness in the lower esophageal sphincter muscle allows stomach contents to flow backward into the esophagus causing esophageal inflamation and damage. Acid reflux causes heartburn, regurgitation and can lead to Barrett esophagus and esophageal cancer. Sleeve gastrectomy is becoming a popular bariatric procedure; however, due to concerns of worsening GERD symptoms with sleeve gastrectomy, GERD sufferers are denied this procedure. There is also a high prevalence of new GERD after sleeve gastrectomy. These patients do not have a good medical or surgical treatment options and they continue to suffer from bothersome GERD symptoms despite maximal medical therapy.
EndoStim is a venture-backed medical device company based in St. Louis, Missouri, and the Hague, the Netherlands, focused on developing innovative active implantable devices. Key investors include Sante Ventures (Austin, TX), Prolog Ventures (St. Louis, MO), Fred Goad (Brentwood, TN), 1998 Co-Investing LLC (St. Louis, MO), Vectis Healthcare & Life Sciences Fund II (St. Louis, MO) and Missouri Technology Corporation/IDEA Funds (Jefferson City, MO), along with many other individual investors. For more information and news about EndoStim, please visit www.endostim.com.
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