NIJMEGEN, Netherlands and ST. LOUIS, May 18, 2015 /PRNewswire/ -- EndoStim announces CE Mark approval and the European launch of the EndoStim II, its second generation LES Stimulation System to treat gastroesophageal reflux disease (GERD).
The EndoStim II device is 25% thinner and 40% less volume compared to EndoStim's first generation device, designed to achieve best patient comfort, acceptance and aesthetics. The EndoStim II device also has improved MRI conditional compatibility for head and extremity imaging procedures, adding support for 3T MRI machines in addition to the 1.5T MRI machines.
EndoStim's minimally-invasive therapy for severe reflux is indicated for patients with chronic GERD with symptom duration of 6 months or longer. Published results through three years of treatment have continually demonstrated an excellent safety profile and ability to control reflux. Additionally, therapy can be wirelessly customized and optimized to fit individual patients as needed.
"It is our goal to continue innovation on the device as well as the therapy to fulfill the needs of patients searching for more optimal long-term solutions for their reflux," comments Paul Goode, Ph.D., Chief Technology Officer at EndoStim. "We thank our surgeons for their important role in the design of our technology."
"The new generation EndoStim device will allow even more patients to benefit from the therapy," explains Dr. Henning G. Schulz, Chief of Surgery at Evangelisches Krankenhaus in Castrop-Rauxel, Germany. "The form of the device – with one rounded edge – allows easy placement and will lead to better aesthetics for the patient."
EndoStim's second generation device is now available in select European markets.
EndoStim is a venture-backed medical device company based in St. Louis, Missouri, and Nijmegen, the Netherlands.
EndoStim's neurostimulation therapy is a minimally-invasive, long-term treatment for severe reflux patients that directly targets the patient's weak or dysfunctional lower esophageal sphincter (LES) muscle between the stomach and the esophagus – often the underlying cause of reflux.
The EndoStim system is CE Marked for patients with gastro-esophageal reflux disease with symptom duration of 6 months or longer. EndoStim 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.
About Reflux Disease
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 weakness or dysfunction in the lower esophageal sphincter muscle allows stomach contents to flow backward into the esophagus causing esophageal inflammation and damage. Acid reflux causes heartburn, regurgitation and can lead to Barrett's esophagus and esophageal cancer. Millions of patients continue to suffer from bothersome GERD symptoms despite maximal medical therapy.
For more information and news about EndoStim, please visit www.endostim.com.