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Does your patient walk as if their feet are stuck to the floor? iNPH idiopathic Normal Pressure

For the Clinician Gait Disturbance

Urinary Incontinence Mild Dementia

Gait Disturbance • Severity of gait disturbance ranges from mild imbalance to a complete inability to stand or walk; many patients describe it as having their feet “stuck to the floor” • A patient’s gait is wide-based, short, slow, and shuffling • Patients may have difficulty turning and lifting their feet, leading to difficulty in negotiating stairs and frequent falls Mild Dementia • Executive functions are affected early in the course of disease, while psychometric findings may remain normal • Later deficits often include psychomotor slowing, impaired attention and concentration, and slowing and reduced precision of fine motor performance • Cognitive symptoms in late-stage disease may include apathy, reduced drive, indifference, brady- phrenia or reduced speech production, and rarely, akinetic mutism Urinary Incontinence • Impairment in bladder control is usually characterized by urinary frequency and urgency in mild cases; while urinary incontinence can occur in more severe cases, some patients display no sign of bladder problems

Learn about iNPH – visit LifeNPH.com Up to 700,0001.2 people in the United States may be living with iNPH and not even know it.

iNPH Normal Parkinson’s Basic Facts About iNPH Gait Gait Gait • It is estimated that 8 in 10 iNPH patients go 2 undiagnosed Typical iNPH patients have • iNPH is treatable and may be the underlying a wide-based short walk cause in an estimated 5% of dementia and (Magnetic Gait). Alzheimer disease patients in the USA3 The footsteps often differ • Diagnosis is based on clinical and radiologic from normal or Parkinson’s gait. findings, and testing with (CSF) drainage, which can predict success of shunt treatment1,5,7

iNPH can appear like Alzheimer’s or Parkinson’s disease4,5

Symptom iNPH Alzheimer’s Parkinson’s Gait disturbance • • • First symptom: May present: Wide-based Narrow shuffle stance Postural instability • • Impaired memory or thinking • • • Disturbance of urinary function • • • Difficulty performing familiar tasks • • • Changes in behavior• • • Rigidity of limbs • of limbs • Bradykinesia • •Present in most patients •Partial or late in some patients CONFIRM Diagnosis Taken together, clinical and radiologic findings, followed by CSF withdrawal and subsequent gait improvement, can confirm the iNPH diagnosis and lead to evaluation for shunt surgery. Begin the process with a clinical exam and take action based on the results at each stage, as shown here6.

Clinical Exam Any Triad Element Present? No Yes

CT / MRI Evaluate other (Evans conditions Index >0.3) Yes

Evaluate Surgical Candidacy Withdrawal of CSF – Tap Test and/or Lumbar Drainage

No Yes

Further evaluation Consider Surgical Treatment with Shunt

Normal iNPH Alzheimer’s iNPH CT scan (axial view) shows MRI image (coronal view) confirms ventriculomegaly with iNPH vs. disproportionately enlarged subarachnoid space normal scan. hydrocephalus (DESH), distinguishing iNPH from Alzheimer’s disease7. EVALUATE Surgical Candidacy

Diagnostic and Observations Shunt Responsive Positive Supplemental Tests and Findings Predictive Value (PPV)

Clinical exam and Any triad element present ~80% PPV7 MRI (DESH) and ventriculomegaly

Lumbar Puncture (LP) Temporary improvement 8 Cerebrospinal Fluid (CSF) of symptoms ~73% PPV withdrawal

External Lumbar Temporary improvement ~90% PPV10 Drainage (ELD) Protocol of symptoms

RECOMMEND Treatment iNPH symptoms may be reversible by CSF shunt therapy. A programmable valve allows for optimized and customized treatment for each individual patient9. The Codman® Hakim® Programmable Valve and the Codman® CERTAS™ Plus Programmable Valve are both adjustable. Using external programmers, the patient’s shunt setting can be changed without additional surgery.

Codman® CERTAS™ Plus Programmable Valve

Codman® Hakim® Programmable Valve

*Programmable valves shown actual size

Identify > Confirm > Evaluate > Recommend Take the first step, go to LifeNPH.com References: 1. Williams, M. A. and J. Malm (2016). “Diagnosis and Treatment of Idiopathic Normal Pressure Hydrocephalus.” Continuum (Minneap Minn) 22(2 Dementia): 579-599. 2. “Thousands of older Americans being misdiagnosed with Alzheimer’s, Parkinson’s” http://www.wpxi.com/news/local/thousands-older- americans-date accessed on May 26, 2016. Hydrocephalus Association. “Who develops Normal Pressure hydrocephalus.” http://www.hydroassoc.org/normal- pressure-hydrocephalus/ accessed on May 26, 2016. 3. Marmarou, A. P. D. (2005). “Foreword.” Guidelines for the Diagnosis and Management of Idiopathic Normal-Pressure Hydrocephalus 57(3): S2-i. 4. Relkin N et al.(2005). “Diagnosing Idiopathic Normal-Pressure Hydrocephalus.” Neurosurgery 57(3)S2:4- 16. 5. Lakhan SE et al. (2008). “The Triad of Idiopathic Normal-Pressure Hydrocephalus A Clinical Practice Case Report.” Libyan J Med. 3(1):54-57. 6. Luciano M, et al. (2008). “When to consider normal pressure hydrocephalus in patient with gait disturbance.” Geriatrics February. 7. Hashimoto, M., et al. (2010). “Diagnosis of idiopathic normal pressure hydrocephalus is supported by MRI-based scheme: a prospective cohort study.” Cerebrospinal Fluid Res 7: 18. 8. Marmarou, A., et al. (2005). “The value of supplemental prognostic tests for the preoperative assessment of idiopathic normal-pressure hydrocephalus.” Neurosurgery 57(3 Suppl): S17-28; discussion ii-v. 9. Bergsneider, M., et al. (2005). “Surgical management of idiopathic normal-pressure hydrocephalus.” Neurosurgery 57(3 Suppl): S29-39; discussion ii-v. 10. Marmarow, A., et al. (2005) “Diagnosis and management of idiopathic normal-pressure hydrocephalus: a prospective study in 151 patients” J Neuro surg 102:987–997

Codman® CERTAS™ Plus Programmable Valve: INDICATIONS: The Codman CERTAS Plus Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus. The Codman CERTAS Tool Kit allows the noninvasive reading or adjustment of the valve setting.

CONTRAINDICATIONS: These devices are contraindicated in patients receiving anticoagulants or known to have a bleeding diathesis. Avoid shunt implantation if is present within the body. Delay the shunt procedure when such as , ventriculitis, peritonitis, bacteremia, and septicemia are present. The BACTISEAL® Catheters are contraindicated in patients with known hypersensitivity to rifampin or clindamycin hydrochloride.

WARNINGS • Choose an implantation site for the valve where the tissue over the valve is not too thick (i.e. tissue thickness < 10mm). Otherwise locating, reading, and adjusting the valve with the tool kit may be difficult (i.e.; multiple attempts may be required) or impossible. If unable to adjust the valve, the valve will maintain a constant operating pressure and the patient should be informed of this risk. • Testing shows that the valve mechanism is resistant to unintended changes in the setting in a 3 Tesla MRI. However, the clinician should confirm the valve setting after a magnetic resonance imaging (MRI) procedure. • Read MRI Information before performing an MRI procedure on a patient implanted with the valve. • Do not interchange the Codman CERTAS Tool Kit (82-8851) components with the Codman CERTAS Therapy Management System TMS (82-8850) components. • The Indicator Tool has a precise operating mechanism and is vulnerable to damage if mishandled. Store and carry all components of the Tool Kit in the storage case when not in use to prevent damage. Replace the Indicator Tool immediately if dropped (or suspected of being dropped) to ensure accurate performance. Replacement Indicator Tools are available from your local Codman representative.

Codman® Hakim® Programmable Valve: INDICATIONS: The Codman Hakim Programmable Valves are implantable devices that provide constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

CONTRAINDICATIONS: The Codman Hakim Programmable Unitized Valve Systems are not recommended for atrial placement. Use the nonunitized versions for this procedure. These devices are contraindicated in patients receiving anticoagulants or known to have a bleeding diathesis. Avoid shunt implantation if infection is present within the body. Delay the shunt procedure when infections such as meningitis, ventriculitis, peritonitis, bacteremia, and septicemia are present.

WARNINGS Subjecting the valve to strong magnetic fields may change the setting of the valve. • The use of Magnetic Resonance (MR) systems up to 3 T will not damage the valve mechanism, but may change the setting of the valve. Confirm the valve setting after an MRI procedure. See Programming the Programmable Valve. • Common magnets greater than 80 gauss, such as household magnets, loudspeaker magnets, and language lab headphone magnets, may affect the valve setting when placed close to the valve. • Magnetic fields generated from microwaves, high-tension wires, electric motors, transformers, etc., do not affect the valve setting. Read MRI Information before performing an MRI procedure on a patient implanted with the programmable valve. The SIPHONGUARD® device is intended to reduce the rapid flow of CSF. It also reduces the ability to prime the shunt system during implantation to a rate of approximately 0.5 mL/minute.

Please consult the Instructions for Use for more detailed information about Warnings, Precautions and appropriate use of the devices.

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region. n Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality. n Warning: Applicable laws restrict these products to sale by or on the order of a physician. n Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

For more information or to place an order, please contact:

United States

USA 800-654-2873 n 888-980-7742 fax integralife.com

Codman, Siphonguard, Bactiseal, Integra, and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. Hakim is a xxxxx Certas is a trademark of Integra LifeSciences or its subsidiaries in the United States and/or other countries. ©2019 Integra LifeSciences Corporation. All rights reserved. Printed in USA. 0810424-2-EN