CE Mark for Second Generation Endostim Neurostimulation Device for GERD

EndoStim has gained CE Mark approval and announced the European launch of its new EndoStim II LES Stimulation System to treat gastroesophageal reflux disease (GERD).

Background

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.

It is is indicated for patients with chronic GERD with severe reflux duration of at least 6 months. The company says 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.

The original Endostim device was launched in 2012 as covered by our pages, here. Compared with its forefather, the EndoStim II device is 25% thinner and 40% less volume, the design clearly targeting patient comfort, acceptance and aesthetics. As with its parent, 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.

Physician comments

“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.”

Company comments

“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.”

Source: PR Newswire

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