Partnering for Pelvic Health EXPANDING OPTIONS FOR BOWEL CONTROL.

Partnering for Pelvic HealthEXPANDING OPTIONS FOR BOWEL CONTROL

• <Insert name(s) of colorectal surgeon presenter(s), practice name/logo, physician photo(s)>

• <Insert patient speaker(s) name(s), condition being treated with InterStim Therapy

Welcome

• Overview of Fecal Incontinence– Prevalence and Burden– Patient Quality of Life– Typical Treatment Pathway

• Introduction to Sacral Neuromodulation– InterStim® Therapy for Bowel Control– Clinical Efficacy – Test for Potential Success

• Practice Management Collaboration

Agenda

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OAB Asthma Diabetes FI Osteoporosis Alzheimer'sOAB1,2 Asthma3 Diabetes4 Osteoporosis6 Alzheimer’s7

• It is estimated that more than 18 million adults in the United States – 1 in 12 – suffer from fecal incontinence (FI)5

• FI is nearly as prevalent as many other chronic diseases and more prevalent than other illnesses well-known to impact many Americans.1-4,6-7

1. Stewart, W.F et al. Prevalence and Burden of Overactive Bladder in the United States.World Jrnl of Urol 2003:20:327-3362. Serels S. The wet patient: understanding patients with overactive bladder and incontinence. Curr Med Res Opin. 2004;20(6):791-801.3. Centers for Disease Control and Prevention Website. http://www.cdc.gov/asthma/brfss/03/lifetime/tableL1.htm. Accessed October 18, 2010. 4. National Diabetes Information Clearinghouse Website. http://www.diabetes.niddk.nih.gov/dm/pubs/statistics/#y_people. Accessed October 18, 2010.5. Whitehead W.E. et al. Fecal Incontinence in US adults: epidemiology and risk factors. Gastroenterology. 2009; 137:512-517. 6. National Osteoporosis Foundation Website. http://www.nof.org/node/40. Accessed October 18, 2010.7. Alzheimer’s Association Website. http://www.alz.org/alzheimers_disease_facts_figures.asp. Accessed October 18, 2010.

FI 5

Fecal Incontinence-More Common Than You Might Think

Fecal Incontinence Quality of Life Scale (FIQOL) ScoresNote: Higher scores translate to higher quality of

life

Medtronic data on file. InterStim Therapy for Bowel Control Prospective Clinical Study. PMA#P080025.

FI Impacts Quality of Life

Studies suggest that only 15%– 45% of FI patients seek treatment1.

Consider the following statistics that support the claim thatfecal incontinence is a hidden condition:• For 84% of patients with FI, the physician was unaware of the patient’s disorder2

• 54% of patients with FI had not discussed the problem with a professional3 • 64% of patients with severe or major FI which had an impact on the quality of

life wanted help with their symptoms4

1. PMA #P080025. Damon H, Guye O, Seigneurin A, et al. Prevalence of anal incontinence in adults and impact on quality-of-life. Gastroenterol Clin Biol. 2006;30(1):37-43. Bano F, Barrington JW. Prevalence of anorectal dysfunction in women attending health care services. Int Urogynecol J Pelvic Floor Dysfunct. 2007;18(1):57-60. 2. PMA #P080025. Damon 2006.3. PMA #P080025. Edwards NI, Jones D. The Prevalence of Faecal Incontinence in Older People Living at Home. Age Ageing. 2001;30(6):503-7. 4. PMA #P080025. Perry S, Shaw C, McGrother C, et al. Prevalence of faecal incontinence in adults aged 40 years or more living in the community. Gut. 2002;50(4):480-484.

Patient Education Needed

Typical FI Treatment Pathway

Conservative treatments include:• Dietary changes

• Anti-diarrheal medications (e.g. loperamide)

• Biofeedback

Discussion– When prescribing medical therapy for FI, what

defines success/failure?– When adequate success is not achieved with one

method, how many others do you typically try?

Optimal Medical Therapy

My practice can offer further options for your patients who aren’t responding favorably to medical therapy:

Diagnostics• Endoanal ultrasound• Anorectal manometry

Therapies• Biofeedback/ physical therapy• InterStim Therapy

(sacral neuromodulation) • Other surgical options

What’s Next for Patients?

ImplanterReferring Physician

CollaborativeProcess toOptimize

Patient Care

Initial Diagnosis

Conservative Treatments

Referral

Further Diagnostics

InterStimTrial Assessment

Implant & Device-related

Follow-up

Ongoing General Patient Care

Practice Management Collaboration

• Focuses mild electrical pulses on the nerves that control the pelvic floor muscles, anal sphincters, and colon.1

• Offers control of symptoms through direct modulation of the nerve activity.1*

1. Kenefick NJ, Emmanuel A, Nicholls RJ. Effect of sacral nerve stimulation on autonomic nerve function. British Journal of Surgery. 2003; 90:1256-1260.

* While the precise mechanism of action for InterStim Therapy has not been fully established, efficacy has been proven in clinical studies.

Sacral Neuromodulation

An established therapy that expands your treatment options for patients with chronic fecal incontinence who have failed or are not candidates for more conservative treatments.

InterStim® TherapySacral Neuromodulation for Bowel Control

1. Minimally invasive option that does not preclude use of alternative treatments

2. Proven clinical safety and efficacy

3. Trial assessment provides informed choice for patient and doctor prior to implant

4. Manufactured by Medtronic, a global leader in medical device technology

InterStim Therapy Benefits

Trust the Experience of MedtronicNeuromodulation Therapies

Chronic Fecal Incontinence, Overactive Bladder and

Urinary Retention

1Humanitarian Device Exemption (HDE): The effectiveness of these devices has not been demonstrated

OCD1

Parkinson’s Disease

Essential Tremor

Chronic Pain

Gastroparesis1

Dystonia1

Severe Spasticity

More than 85,000 patients worldwide have received

InterStim Therapy

InterStim Therapy Bowel Control Study

1. Wexner SD, Coller JA, et al. Ann Surg. 2010 Mar;251(3):441-9. 2. Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2011.

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Per-protocol (n=106)

Baseline

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1.9

Modified Worst Case (MWC)(n=120)

Baseline

12 Months

12 Months

Clinical Efficacy: Reduction in Episodes

Clinical Efficacy: Complete Continence

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InterStim Therapy Bowel Control

Study1,2

Per-protocol (n=106)

MWC (n=120)

41%36%

1. Wexner SD, Coller JA, et al. Ann Surg. 2010 Mar;251(3):441-9. 2. Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2011.3. Tjandra JJ et al. Sacral nerve stimulation is more effective than optimal medical therapy for severe fecal incontinence: a randomized, controlled study. Dis Colon Rectum. May 2008;51(5):494-502.

47%

Tjandra RCT3

SNS group(n=53)

Clinical Efficacy: Quality of Life

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Scale 1 - Lifestyle 2.31 3.22 3.26 3.36 3.32 3.52

Scale 2 - Coping/Behavior 1.49 2.64 2.69 2.77 2.69 2.7

Scale 3 - Depression/Self-Perception

2.53 3.33 3.48 3.54 3.58 3.77

Scale 4 - Embarrassment 1.6 2.73 2.75 2.81 2.76 2.95

Baseline (n=119)

3-Months (n=116)

6-Months (n=109)

12-Months (n=107)

24-Months (n=68)

36-Months (n=30)

InterStim Therapy Bowel Control Study

1. Wexner SD, Coller JA, et al. Ann Surg. 2010 Mar;251(3):441-9.

The most common adverse events (≥5%) reported during the implant phase in clinical study included:1

– Implant site pain– Paresthesia – Implant site infection – Change in sensation of stimulation– Urinary incontinence – Diarrhea

1. Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2011

For additional safety information, please refer to the Important Safety Information on handouts.

Adverse Events

• who have frequent bowel accidents

• who have had bowel accidents for the past year or more

• who have failed or are not candidates for conservative treatments such as diet modification, anti-diarrheal medications or biofeedback

I would consider testing InterStim Therapy with patients:

• Patient trials the therapy for several days to determine whether symptom improvement is achieved

• Provides informed choice for patient and doctor

If indicated, your patients can try InterStim Therapy through a minimally invasive trial assessment

Complications can occur with the trial assessment, including movement of the wire, technical problems with the device, and some temporary pain.

Test for Potential Success

• Through a minimally invasive procedure initiated in the office or in an outpatient hospital setting, a lead (thin wire) is placed near the sacral nerve (target S3).

• The lead is connected to an external test stimulator worn on the patient’s waistband for several days.

• The patient will be asked to record bowel behavior during the trial.

• If patient experiences success, a neurostimulator may be implanted.

• If patient does not experience success, a subsequent trial assessment may be recommended.

• If patient still does not experience success, the lead will be removed and the patient will immediately be able to try other options.

Overview of Trial Assessment

• Practical and extensive experience with InterStim Therapy

• Offering your patients a minimally invasive option that can restore function1

• We will collaborate to develop a follow-up plan once symptoms are successfully treated

1. Restored function as defined as a ≥50% reduction in weekly fecal incontinent episodes at 12 months post implant in clinical studies.

Benefits of Referring Your Patients

ImplanterReferring Physician


Patient Care

Initial Diagnosis


Referral

Further Diagnostics



Follow-up


ImplanterReferring Physician ImplanterReferring PhysicianReferring Physician


Patient Care

Initial Diagnosis

Initial Diagnosis



ReferralReferral

Further Diagnostics

Further Diagnostics




Follow-up


Follow-up



• “I would like to refer you to a specialist who will evaluate your condition further and determine if InterStim Therapy might be an option for you.”

• “The InterStim trial assessment will give you a chance to find out during a short trial period if long-term therapy may be a good option for you.”

• “InterStim Therapy is an established therapy that is FDA approved for chronic fecal incontinence patients who have not benefited from conventional therapies.”

• “InterStim is manufactured by Medtronic, a global leader in medical device technology.”

What Should You Tell Your Patients?

• Fecal incontinence (FI) is very common and may impact a person’s quality of life.

• Patients may be embarrassed to discuss FI symptoms and are often unaware of the new treatment options available.

• If conservative treatments have been unsuccessful, refer patients to my practice to determine if InterStim Therapy is an option for them.

• By partnering, you can expand patients’ treatment options and help find the best solution to manage their symptoms.

• Together we can improve the quality of life for patients with bowel control problems.

Summary

Important Safety InformationInterStim® Therapy for Urinary Control is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.

The following Warning applies only to InterStim Therapy for Urinary Control:

Warning: This therapy is not intended for patients with mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture.

InterStim® Therapy for Bowel Control is indicated for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments. Contraindications for Urinary Control and for Bowel Control: Diathermy. Patients who have not demonstrated an appropriate response to test stimulation or are unable to operate the neurostimulator. Precautions/Adverse Events:For Urinary Control: Safety and effectiveness have not been established for bilateral stimulation; pregnancy, unborn fetus, and delivery; pediatric use under the age of 16; or for patients with neurological disease origins such as multiple sclerosis. For Bowel Control: Safety and effectiveness have not been established for bilateral stimulation; pregnancy, unborn fetus, and delivery; pediatric use under the age of 18; or for patients with progressive, systemic neurological diseases. For Urinary Control and for Bowel Control: The system may be affected by or adversely affect cardiac devices, electrocautery, defibrillators, ultrasonic equipment, radiation therapy, MRI, theft detectors/ screening devices. Adverse events include pain at the implant sites, new pain, lead migration, infection, technical or device problems, adverse change in bowel or voiding function, and undesirable stimulation or sensations, including jolting or shock sensations. For full prescribing information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com. Product technical manual must be reviewed prior to use for detailed disclosure.

USA Rx Only. Rev 0409

http://www.medtronic.com/

Partnering for Pelvic Health EXPANDING OPTIONS FOR BOWEL CONTROL.

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