Medtronic Inc. has
announced that it has received United States Food and Drug Administration (FDA)
approval under a humanitarian device exemption (HDE) for the Medtronic Enterra
II System.
The system is used to
treat chronic intractable nausea and vomiting associated with gastroparesis of
diabetic or unknown origin when more conservative treatments fail or cannot be
tolerated.
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Medtronic Enterra Therapy consists of a small medical device called a neurostimulator which is implanted under the skin usually in the lower abdominal region.
Two insulated wires
called leads are implanted in the stomach wall muscle and then connected to the
neurostimulator which delivers mild electrical pulses through the leads to
stimulate the smooth muscles of the lower stomach.
![New Findings on Bacteria Linked to Stomach Disorders]( "New Findings on Bacteria Linked to Stomach Disorders")
Certain genetic variations are associated with susceptibility to Helicobacter pylori , a bacteria that is a major cause of gastritis, stomach ulcers and is linked to stomach cancer.
After the device is implanted the doctor uses a handheld external programmer to noninvasively adjust the neurostimulator and customize the stimulation to each patient's needs. Medtronic Enterra Therapy can be turned on and off at any time using the physician programmer.
"Enterra Therapy is an important option for people suffering from the severe effects of gastroparesis including chronic nausea and vomiting" said Dr. Parkman, M.D. Professor of Medicine at Temple University School of Medicine and Director of the GI Motility Laboratory at Temple University Hospital. "The new advanced system simplifies the implantation process and is easy to program."
Source: Medindia
New Findings on Bacteria Linked to Stomach Disorders
Certain genetic variations are associated with susceptibility to Helicobacter pylori , a bacteria that is a major cause of gastritis, stomach ulcers and is linked to stomach cancer.
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After the device is implanted the doctor uses a handheld external programmer to noninvasively adjust the neurostimulator and customize the stimulation to each patient's needs. Medtronic Enterra Therapy can be turned on and off at any time using the physician programmer.
"Enterra Therapy is an important option for people suffering from the severe effects of gastroparesis including chronic nausea and vomiting" said Dr. Parkman, M.D. Professor of Medicine at Temple University School of Medicine and Director of the GI Motility Laboratory at Temple University Hospital. "The new advanced system simplifies the implantation process and is easy to program."
Source: Medindia
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