A Medical Device Daily Staff Report

EndoStim (The Hague, the Netherlands) reported that it has received the CE mark for its LES Stimulation system for the treatment of gastro-esophageal reflux disease (GERD).

The EndoStim system uses low energy electrical pulses to strengthen a weak or dysfunctional lower esophageal sphincter (LES) muscle which is the underlying cause of GERD. EndoStim's device, implanted through a minimally-invasive laparoscopic procedure, is intended to treat acid reflux and eliminate the need for daily PPI medication. In clinical trials the treatment was able to significantly reduce acid exposure and related symptoms of heartburn and regurgitation without causing any gastrointestinal side effects seen with other anti-reflux procedures.

Bevil Hogg, president/CEO of EndoStim, stated, "EndoStim is very excited to offer a truly revolutionary treatment to patients with severe GERD – one that is designed to normalize esophageal function. EndoStim is working closely with leading GERD experts throughout the world to develop 'Centers of Excellence' offering EndoStim treatment for the millions of GERD sufferers worldwide."

The company said that clinical results from the CE study demonstrate dramatic improvement of acid reflux while allowing for normal esophageal function, such as swallowing and belching. The data indicate that 100% of patients who received EndoStim treatment for 12 months were able to stop daily PPI use and 77% achieved normalization or greater than 50% reduction in abnormal esophageal acid exposure.

EndoStim LES stimulation therapy has shown both daytime and nighttime improvement in heartburn symptoms and regurgitation.

Leonardo Rodriguez, MD, the lead investigator for the CE mark trial conducted in Santiago, Chile, says, "I believe that EndoStim LES stimulation therapy is the ideal treatment option for patients with severe GERD who are unhappy with their medical therapy or want freedom from life-long dependence on medications. I am very impressed with the clinical results and look forward to offering EndoStim therapy to my GERD patients."

EndoStim is continuing trials in key centers across South America, Europe, and Asia.

Actuated in distribution accord with Kimal

Actuated Medical (Bellefonte, Pennsylvania) reached agreement with Kimal (Uxbridge, UK) to distribute their TubeClear system throughout Europe, the Middle East, and North Africa. Kimal is a medical device distributor.

TubeClear uses Actuated Medical's mechanical motion technology to clear clogs in nasogastric (NG) feeding and decompression tubes. Clearing NG tubes prevents disruptions in feeding and medication delivery and allows clinicians to maintain their focus on improving patient care. The system, which is comprised of reusable control boxes and single-use clearing stems, is designed, developed, and manufactured by Actuated in the U.S.

Maureen Mulvihill, PhD, president of Actuated, commented that, "We are thrilled to partner with a quality organization like Kimal and proud to have them distribute our products across the globe. This system will speed the process of unclogging tubes, save healthcare organizations significant money, and ultimately improve clinical care. The real bonus of this new partnership is the addition of Alan Press, CEO of Kimal, to our board of directors."

TubeClear has been cleared by the FDA for commercial distribution and CE marked. It is available throughout the U.S, Europe, the Middle East and North Africa.

Actuated Medical is a device company that focuses on state-of-the-art, minimally invasive instruments for clearing occlusions, penetrating tissue, and enabling the emerging MRI-guided surgical procedure industry. A full-service firm with U.S.-based design, development, and manufacturing, the company ultimately enhances clinical care and delivers improved patient outcomes.

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