1. Enterra® Therapy Partnering for Gastric Health
Expanding Options for Treating Gastroparesis Symptoms

2. Welcome
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3. 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

4. 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

5. 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)

6. 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)

7. 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. 2006;18(4):263-28

8. Gastric Electrical Stimulation ENTERRA THERAPY
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

9. 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
500 US Implants
1000 US Implants
1500 US Implants
8000 US Implants
2009 9

10. 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.

11. 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 low-frequency, high-energy method

12. Gastric Pacing vs. Neurostimulation
 Neurostimulation: Frequency > Intrinsic
Low Energy
Energy
Frequency
Pacing: Frequency ~ Intrinsic
High Energy 

13. 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):

14. The Enterra System

15. Enterra Therapy U.S. Indication
“Enterra Therapy is indicated for the treatment of patients with chronic, intractable (drug-refractory) 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

16. 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.

17. Practice Management Collaboration
Specialist/Implanter
Referring Physician
Collaborative Process to Optimize Patient Care
Initial Diagnosis
Behavioral
Therapies
Referral
Further Diagnostics
Enterra Implant
Device-related
Follow-up
Ongoing General Patient Care

18. Trust the Experience of Medtronic
Neuromodulation Therapies
OCD1
Parkinson’s Disease
Essential Tremor
Chronic Pain
Gastroparesis1
Bladder Control and Bowel Control
Dystonia1
Severe Spasticity
1Humanitarian Device Exemption (HDE): The effectiveness of these devices has not been demonstrated.

19. Key Patient Selection Criteria
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
Patient
Idiopathic or diabetic gastroparesis
Chronic, severe vomiting or nausea
Drug-refractory

20. 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

21. 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

22. 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.

23. Important Safety Information