Enterra® Therapy
• Partnering for Gastric Health
• Expanding Options for Treating
Gastroparesis Symptoms
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Welcome
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procedures, and services provided at physician practice>
Agenda
• Overview of Gastroparesis
– What is it?
– Patient Quality of Life
– Typical Treatment Options
• Introduction to Gastric Electric Stimulation
– History
– Pacing vs Neurostimulation
– Enterra® Therapy System
• Practice Management Collaboration
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What is Gastroparesis?
Definition
Gastroparesis is a stomach disorder in which food is digested more
slowly than normal. With gastroparesis, the stomach muscles work poorly
(or not at all), thus preventing the stomach from emptying properly. For
some people, this condition results in serious nausea and vomiting that
cannot be adequately controlled with standard medications.
Symptoms
• Nausea
• Vomiting
• Abdominal bloating
• Abdominal pain
• Early satiety
• Heartburn or gastroesophageal reflux disease (GERD)
• Changes in blood sugar levels
• Lack of appetite
• Excessive weight loss/gain
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What is Gastroparesis?
Etiologies
In a study of 146 patients, the most
common origins were*:
• Idiopathic (35.6%)
• Diabetic (29%)
• Others (35.4%)
*Soykan I, Sivri B, Sarosiek I, Kiernan B, McCallum RW. Demography, clinical
characteristics, psychological and abuse profiles, treatment, and long-term follow-up of
patients with gastroparesis.
Dig Dis Sci. 1998;43(11)
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What is Gastroparesis?
Impact
The impact of gastroparesis on physical well-being can be devastating. It
can cause chronic nausea and vomiting and lead to malnutrition and
inadequate blood sugar levels. Living with gastroparesis also affects
emotional well-being – the constant discomfort of chronic nausea and
vomiting can affect school and work performance, family and personal
relationships, and social activities.
Diagnosis
Diagnosis is based on a complete medical history, physical examination,
and tests that may include:
• Upper gastrointestinal endoscopy
• Gastric emptying test (GET)
• Gastroduodenal manometry
• Electrogastrography (EGG)
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Treatment Options for Gastroparesis
There is no cure for gastroparesis but there are treatment options
that can control the symptoms of chronic vomiting and nausea.
Often, multiple therapies are used in combination*. An overview of
care for gastroparesis includes:
*Abell TL, Bernstein RK, Cutts T, et al. Treatment of gastroparesis: a multidisciplinary clinical review.
Neurogastroenterol Motil.7 2006;18(4):263-28
What’s Next for Gastroparesis Patients?
My practice can offer an option for your patients
who aren’t responding favorably to their existing
regimen.
Gastric Electrical Stimulation
ENTERRA THERAPY
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Gastric Stimulation Program History
1st Clinical Case
Study
Animal Study, U.
Tenn
GEMS Multicenter
Feasib. Trial
Gastric Emptying
Study
U VA Pacing
Studies
WAVESS Trial
Compassionate Use
CUESS
Gastric HUD/HDE
US Therapy Launch
(DDW)
100 US Implants
US RCT
European Launch
2009
500 US Implants
1000 US Implants
1500 US Implants
8000 US Implants
1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
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…
2014
History of Gastric Electrical Stimulation
1963
Bilgutay et al.- The concept of electrical stimulation started
when gastric stimulation was practiced for the treatment of
postoperative ileus.
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Pacing vs. Neurostimulation
Gastric pacing is a commonly used phrase for gastric
electrical stimulation (GES). Enterra® Therapy utilizes
gastric electrical stimulation or neurostimulation.
•
Neurostimulation is an activation of a nausea and
vomiting control mechanism, utilizing a high-frequency,
low-energy stimulation to achieve symptomatic relief
•
Pacing is an application of an electrical stimulus that
activates contraction of gastric smooth muscle,
entraining at the rate of the intrinsic slow wave by a lowfrequency, high-energy method
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Gastric Pacing vs. Neurostimulation

Neurostimulation: Frequency > Intrinsic
Low Energy
Frequency
Pacing: Frequency ~ Intrinsic
High Energy

Energy
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Enterra Therapy for Gastroparesis
Enterra Therapy with gastric electrical stimulation
(GES) is an innovative approach to treating patients
with chronic, intractable (drug-refractory) nausea and
vomiting secondary to gastroparesis of idiopathic or
diabetic origin.
The therapy uses mild electrical pulses to stimulate the
nerves of the antrum. This stimulation may reduce the
symptoms of nausea and the number of vomiting
episodes related to gastroparesis.* Introduced by
Medtronic, Inc., the world leader in implantable medical
technologies, Enterra Therapy can be turned off or
removed if there is no longer a benefit.
*Abell T, McCallum R, Hocking M, et al. Gastric electrical stimulation for medically refractory
gastroparesis. Grastroenterology. 2003; 125(2):421-428
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The Enterra System
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Enterra Therapy U.S. Indication
“Enterra Therapy is indicated for the treatment
of patients with chronic, intractable (drugrefractory) nausea and vomiting secondary to
gastroparesis of diabetic or idiopathic origin in
patients aged 18 to 70 years.”
– Designated as Humanitarian Use Device (HUD)
September 23, 1999 by the FDA
– Approved as Humanitarian Device Exemption
(HDE) March 31, 2000 by the FDA
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FDA Approval of Humanitarian Device Exemption
Enterra Therapy for Gastric Electrical Stimulation has been approved by the
FDA under a Humanitarian Device Exemption (HDE)* for the treatment of
chronic intractable (drug refractory) nausea and vomiting secondary to
gastroparesis of diabetic or idiopathic etiology. A Humanitarian Use Device is
an FDA classification covering medical devices for the treatment of conditions
affecting fewer than 4,000 new patients per year.
The FDA reviewed the safety of the device and determined that the probable
health benefits outweigh the risks of injury or illness from its use. Efficacy of
treatment, however, has not been established by large clinical trials. Surgery to
implant Enterra Therapy for Gastric Electrical Stimulation can only be
performed in medical centers that specifically approve its use and have
institutional review board (IRB) approval.
*Humanitarian Device: The effectiveness of this device for the treatment of Gastric
Electrical Stimulation has not been established.
Practice Management Collaboration
Initial
Diagnosis
Behavioral
Therapies
Ongoing General
Patient Care
Collaborative
Process to
Optimize
Patient Care
Device-related
Follow-up
Enterra
Implant
Referring Physician
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Referral
Further
Diagnostics
Specialist/Implanter
Trust the Experience of Medtronic
Neuromodulation Therapies
OCD1
Parkinson’s Disease
Essential Tremor
Dystonia1
Severe Spasticity
Chronic Pain
Gastroparesis1
Bladder Control and
Bowel Control
1Humanitarian
Device Exemption (HDE): The effectiveness of these devices has not been demonstrated.
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Key Patient Selection Criteria
Patient
• Idiopathic or
diabetic
gastroparesis
• Chronic, severe
vomiting or nausea
• Drug-refractory
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Physician
• weighs all available treatment
options
• evaluates appropriate patients
• educates patient and family
about therapy and expectations
• discusses surgical procedure of
Enterra Therapy with patient and
family
• defines follow-up schedule and
expectations
Adverse Events
Enterra Therapy has risks similar to any surgical procedure,
including swelling, bruising, bleeding, and infection. In addition
to risks related to a medical procedure, adverse events related
to the system may include:
• Infection
• Pain at the implant site
• Lead penetration
• Bowel obstruction or perforation
• Programming difficulty
• Undesirable change in stimulation
• Lead entanglement or erosion
• Irritation/inflammation over the implant site
• Device mechanical or electrical problems
Any of these may require additional surgery or cause return
of symptoms. Additional information on Enterra Therapy is available at
www.enterratherapy.com.
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Benefits of Referring Your Patients
• Manage treatment options for your
Gastroparesis patients
• Specialized training and education
in gastric electrical stimulation
• Extensive experience with
leading-edge technology
and interventions related
to neuromodulation
• Collaborate to
develop a follow-up
plan once symptoms
are successfully treated
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Summary
• Gastroparesis is very rare and debilitating disease and
significantly impacts a person’s health and quality of
life.
• Patients are often unaware of the various treatment
options available.
• If conservative treatments have been unsuccessful,
refer patients to a specialist for alternative treatment
options.
• By partnering with a specialist, treatment options can
be expanded to help find the best solution to manage
gastroparesis symptoms.
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Important Safety Information
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