Apart from one patient dropping out, evaluations conducted at those three- and six-month marks have suggested that the approach does lead to "significant improvement" in terms of symptom relief, with no gastrointestinal side effects. As a result, all were able to stop taking the GERD medications they had been taking prior to implantation.
One expert was skeptical of the findings.
"There have a number of new techniques that have been explored in recent years," said Dr. Perry Milman, assistant clinical professor of medicine at the Albert Einstein College of Medicine, in New York City. "But with all the ones that we have seen, the statistics so far show that, invariably, after a year's period of time 50 percent of the patients who were able to successfully get off of their medications end up going back on them."
"I would also be hard-pressed to understand why a patient who would be reluctant to undergo standard stomach surgery would accept this kind of implantation technique," said Milman, who also is an adjunct assistant clinical professor of medicine at the State University of New York at Stony Brook, in Long Island. "You have something implanted into your abdomen that will involve anesthesia. And, really, anesthesia is the most invasive aspect of all these procedures."
"Regardless, the number of patients in these studies are very tiny, obviously," he added. "So I'm certainly not going to be running at this point to send anyone in for this. It's still way, way too early to say anything about this approach one way or another."
Although the device, known as EndoStim, was just approved for clinical use in the European Union, the procedure is not yet available to patients in the United States, where testing is still under way. Depending on further study results, Soffer suggested that the soonest it might be available for American GERD patients would be 2016.
But at what cost?
Although Soffer described the operation itself as a "simple, one-shot deal," it is not yet possible to itemize the full cost of the surgery and device. He did note, however, that the device would have a shelf life of about 10 years, much like most pacemakers, at which point replacement surgery would be required.
Funding for all the studies was provided by the manufacturer of the stimulation device, EndoStim BV, which is based in the Hague, The Netherlands. Data and conclusions presented at medical meetings should be viewed as preliminary until published in a peer-reviewed journal.
For more on GERD, visit the U.S. National Library of Medicine.
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