Description of Enterra Therapy or gastic pacemaker

Anne (AU) has one and has benefitted greatly.

• Enterra Therapy may reduce symptoms of nausea and vomiting for many people suffering from              gastroparesis when drugs are ineffective. The therapy is reversible and can be turned off at anytime.

Will the Enterra Therapy cure my stomach problems?

• This therapy is not a cure, but may be a beneficial treatment for your symptoms. How well it relieves symptoms varies from person to person.

What is an Enterra Therapy (Gastric Electrical Stimulation) System?
Enterra Therapy is prescribed by a physician. The Enterra Therapy system components include:

• An implanted neurostimulator that is usually surgically placed in the lower abdomen                  region.
• Two intramuscular leads (wires) with electrodes implanted in the muscle wall of your stomach.
• A programmer that the physician uses to control and adjust the settings of your implantedneurostimulator.

Risks and Probable Benefits of Enterra Therapy 

Enterra Therapy may reduce symptoms of nausea and vomiting for certain people suffering from
gastroparesis when drugs are ineffective. The therapy is reversible and can be turned off at any
time.

Results of clinical studies done on Enterra Therapy.
Enterra Therapy has been used successfully in people over several years. Enterra Stimulation is
approved for the treatment of nausea and vomiting from gastroparesis when drug treatments are
not effective.

A worldwide clinical trial was conducted with people who had severe symptoms of nausea and
vomiting associated with gastroparesis. Clinical trials are controlled studies carried out to
evaluate how well a therapy treats a condition and how safe it is. The study results help
government agencies (such as the FDA) decide whether to approve a device or therapy for
commercial use.

The interim results of the clinical trial (Medtronic FDA Application H990014) show that the
therapy successfully reduces symptoms of nausea and vomiting in patients for whom drug
treatments did not work. The average number of vomiting episodes before implant and at 6 and
12 months after surgery are shown in the chart.

Weekly Vomiting Frequency

•  100% of patients experienced a reduction of vomiting at 12 months following implant versus baseline.
• 93% of patients experienced a reduction of vomiting episodes greater than 50% at 12 months following implant vesus baseline.
• 53% of patients experienced a reduction of vomiting episodes greater than 80% at 12  months following implant versus baseline.
• 66% of patients experienced a reduction of vomiting to less than 7 episodes per week at 12 months following implant.

NOTE: (Medtronic FDA Application H990014)

The interim results of clinical studies indicate that Enterra Therapy may be a beneficial treatment
alternative for patients suffering from drug refractory gastroparesis of idiopathic or diabetic
etiology. Patients treated with Enterra Therapy had a significant reduction in vomiting frequency
at 6 and 12 months. Patients also experienced improvements in other upper gastrointestinal
symptoms, solid food intake, and a reduction in hypoglycemic attacks (diabetics), as well as
significant improvements in health related quality of life.
What problems did patients experience in this study?
The adverse events observed during the clinical evaluation of the Enterra Therapy system
include: lead impedance out of range, device infections, device erosion, device migration,
stomach wall perforation, upper gastro-intestinal (GI) symptoms, extra-abdominal pain, feeding
tube complications, lower GI symptoms, dehydration, bone- and joint-related pain, acute
diabetic complications, dysphagia, cardiovascular/renal related events, urinary tract infections,
stress incontinence, fever, and infections (sinus, pink eye, herpes zoster). These effects were
related to the device, implant, underlying disease, other therapies, or other.

Other potential complications which were not seen during clinical evaluation include: undesirable
change in stimulation, possibly related to cellular charges around the electrodes, shifts in
electrode position, loose electrical connections, or lead fractures; hemorrhage, hematoma, and
possible GI complications resulting from the surgical procedure to implant the neurostimulator
and leads; migration of lead or stimulator, which may necessitate surgical revision; persistent pain
at the neurostimulator site; seroma at the neurostimulator site; allergenic or immune system
response to implanted materials; and loss of therapeutic effect.

Enterra Therapy Surgery

Implantation of the Enterra Therapy system is a surgical procedure done under general
anesthesia. During this operation, your surgeon will implant two small electrodes in the muscle
wall of the stomach. The lead will then be connected to the implantable neurostimulator that is
placed beneath the skin, and usually positioned below the rib cage and above the belt line in your
abdomen. This operation may last from one to three hours. You should speak with your doctor
and/or surgeon beforehand so that you understand how the operation will be performed, what
the risks of surgery are, and what you should expect during your post-operative recovery.

NOTE: Cardiac pacemakers may be affected by the Enterra Therapy if the two systems are
too close to each other. Tell your doctor if you have a cardiac pacemaker so he or she can
assess any possible electrical interference problems and decide if you can also have Enterra
Therapy.

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