Zhion August 8, 2005

Many people can get relief from have
gastroesophageal reflux disease (GERD)
symptoms by changing their diet, life-style and/or using drugs. Drugs commonly
used to manage GERD symptoms include proton pump inhibitors (PPIs), such as
Prilosec® and Prevacid®, H2 receptor antagonists, such as Pepcid®,
Tagamet® and Zantac®, and common antacids, such as Maalox® or
Mylanta®. In the past, when the drugs became ineffective, anti-reflux surgery was
almost the only alternative treatment for GERD symptoms.

On April 22, 2003, Enteryx Procedure Kit (Manufacturer: Enteric Medical
Technologies, Inc.) was approved by FDA to treat GERD symptoms. The Enteryx
procedure became another alternative treatment to long-term drug use or anti-
reflux surgery for GERD. Enteryx is a permanently implanted device but the
Enteryx procedure is a minimally invasive treatment option, performed on an
outpatient basis. Enteryx is a liquid polymeric material that is injected into the
muscle of the lower esophageal sphincter (LES), through an endoscope (a tube
used to look at the esophagus and stomach). After the injection, the solvent
separates away, leaving Enteryx to solidify into a spongy material, i.e. a permanent
implant in the sphincter muscle. Enteryx is intended to reduce the symptoms of
GERD by helping the LES keep stomach fluids and acids from backing up into the
esophagus. It does not affect the stomachÂ’s ability to produce acid or other
digestive fluids. The Enteryx device kit comes with an injection catheter, syringes,
and needles are also contained within the device kit.

Enteryx device is used in patients who have persistent symptoms of
gastroesophageal reflux disease (GERD) with regular use of PPI medications. If
these conditions apply, and your symptoms have responded well to one of the
medications, then you may be a candidate for Enteryx. However, you should avoid
Enteryx, if you have distended veins in the esophagus, portal hypertension or
chronic liver disease.

Enteryx procedure is simple. After the patient has received the sedation, the
doctor will place an endoscope down into the patentÂ’s esophagus. The
endoscope allows the doctor to see the lining of esophagus and stomach. The
doctor will then find the place for injection. The doctor will insert a small tube
(catheter) with a needle on its end through the endoscope to the place where the
injection is needed. The doctor injects Enteryx material through the catheter and
needle. The doctor will use a fluoroscope to check where the Enteryx is injected.
The procedure typically takes less than one hour. After the procedure is
completed, the patient will be monitored in a recovery room. The patient usually
can go home on the same day. However, the patient needs to arrange for
someone to drive him home.

In a study, most patients had at least one side effect of the treatment. In a study,
about 90% had chest pain below the breastbone after the procedure. However,
half of these cases, the pain disappeared in a week. Most patients needed pain
medications to treat their pain. Specifically, about 20% had a hard time to swallow
after the procedure. This could persist several days or longer. About 10% had
fevers right after the procedure. About 10% had sore throats after the procedure
and this condition persisted for a week. About 6-7% had more gas including
bloating, belching and flatulence after the procedure. Other side effects include
nausea, garlic body-odor, bleeding, ulceration, erosion, perforation, fistula and
mediastinitis. After the procedure, after 67% of the patients was no longer taking
any of the PPI drugs.

Reference www.bostonscientific.com/patient-education August 8, 2005


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