Provides the exibility, simplicity, control and con dence to ...app.sales.integralife.com/csf-management/programmable...No live bacteria are observed. Control Catheter3 Coagulase-negative

Provides the flexibility, simplicity, control and confidence to manage the needs of the hydrocephalus patient.

A DIVISION OF INTEGRA LIFESCIENCES COMPANY

2

Managing Hydrocephalus can be a challenge. That is why Codman® offers a complete range of CERTAS™ Plus Programmable Valves for most patient types and surgical preferences.

Broad range of settings, designs and configurations to meet the needs of most patients.

n 8 settings including ‘Virtual Off’.

n MRI resistant up to 3 Tesla.

n 3 different designs: Regular, Small and Right Angle housing.

n Available with integrated SiphonGuard® and/or unitized Bactiseal®.

Instant digital feedback provides reliable and faster post-operative adjustment.1

n Simple steps with visual guidance.

n Accurate and reliable setting change.

n Ergonomic design.

Codman® CERTAS™ Plus Programmable Valve

Codman® CERTAS™ Plus Electronic Tool Kit

1. Compared to Codman CERTAS® Tool Kit.

Flexibility

Simplicity

Right Angle

Small Regular

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST and AFRICA ONLYDOCUMENT FOR USE IN EUROPE, MIDDLE-EAST and AFRICA ONLY

3

A pledge of reducing gram positive bacterial infections.

n Antibiotic impregnated antimicrobial shunt catheter system.

n Reduces gram positive bacterial colonization on the catheter surface for up to 50 days.1

n Available in an unitized or stand-alone configuration.

The Codman® CERTAS™ Plus Programmable Valve integrated with the SiphonGuard® Anti-Siphon Device reduces the risk of overdrainage.

n The added safety of a pathway that remains open.

n Designed to be unaffected by encapsulation, external pressure or deteriorating pliability.

n Location independent.

n Available in integrated or stand-alone / add-on configurations.

Codman CERTAS® Tool Kit

Bactiseal® Antimicrobial Impregnated Catheter

SiphonGuard® Anti-Siphon Device

1. Bayston R, Ashraf W, Bhundia C. Mode of action of an antimicrobial biomaterial for use in hydrocephalus shunts.J. Antimicrobial Chemotherapy. 2004; 53:778-782.

Control

Versatility

Confidence

Allow for non-invasive monitoring and adjusting of the valve pressure setting.

n 2 Locator Tool options to accommodate different tissue thicknesses.

n Indicator Tool for valve setting reading.

n Adjustment Tool for valve setting change.

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST and AFRICA ONLY

44 DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST and AFRICA ONLY

Codman® CERTAS™ Plus Programmable ValveA versatile solution for patients with hydrocephalus.

Pres

sure

(m

mH

20)

Average Pressure settings

Settings

Flow rate (ml/hr)

250

200

150

100

50

00 10 20 30 40 50

215

180

145

110

80

50

25

7

6

5

4

3

2

1

MRI resistance up to 3 Teslan The valve is designed to withstand unintended

pressure setting changes due to external magnetic influences, including MRI up to 3 Tesla.1

3 different designs

n Inline Regular housing is designed for most patients.

n Inline Small low profile housing provides flexibility. Connectors are pointing toward skull to reduce localized tissue stresses and potential necrosis for patients.

n Right Angle housing is designed for burr hole placement while maintaining similar reservoir size to inline design.

8 settings including ‘Virtual Off’n 7 settings ranging from 25 mm H

2O to 215 mm H

2O

to optimize shunt performance.

n Additional 8th setting, known as ‘Virtual Off’, with a minimum operating pressure greater than 400 mm H

2O.

1. Clinician should confirm the valve setting after a Magnetic Resonance Imaging procedure (MRI)


5DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST and AFRICA ONLY

Codman® CERTAS™ Plus Programmable ValveA versatile solution for patients with hydrocephalus.

Available with integrated SiphonGuard® and/or unitized Bactiseal®n SiphonGuard® Anti-Siphon Device reduces the risk of overdrainage and is position independent, allowing

maximum treatment flexibility for the patient.2

n Bactiseal® Antimicrobial Impregnated Catheters reduce gram positive bacterial colonization up to 50 days3. Codman® CERTAS™ Plus is the only Codman® programmable valve available with unitized antimicrobial impregnated catheter.

8 settings including 'Virtual Off'

Adjustable Valve Mechanism with Ruby Bushing, Ball & Seat Integrated

SiphonGuard® Anti-Siphon Device (Optional)

MRI Resistant up to 3 Tesla1

Unitized Bactiseal® Antimicrobial Impregnated Catheter

(Optional)

Integrated Reservoir Direction of flow arrow

1. The clinician should confirm the valve setting after a magnetic resonance imaging (MRI) procedure2. Using the Codman HAKIM Programmable Valve with SiphonGuard Hashimoto, Mukai and Tsukada. The Neurosurgery Bulletin, Sept. 20043. Bayston R, Ashraf W, Bhundia C. Mode of action of an antimicrobial biomaterial for use in hydrocephalus shunts. J. Antimicrobial Chemotherapy. 2004; 53:778-782.


Codman® CERTAS™ Plus Electronic Tool KitA simplified Tool Kit that reduces post-operative reprogramming time.1

Codman CERTAS® Tool KitA versatile Tool Kit for non-invasive adjustment.

Simple steps with visual guidancen Provides clear and easy-to-follow visual guidance to locate the valve.

n Locating dot provides instant feedback and shortens procedure time.1

Accurate and reliable setting changen Offers tactile feedback during adjustment for more confidence in setting changes.

n Number and checkmark indicator gives assurance of proper setting.

n Features a safety stop between settings 1 and 8.

Ergonomic designn The soft concave section of the locator tool base reduces patient discomfort.1

n The handle design improves ease and comfort in handling the Tool Kit.1

1. Compared to Codman CERTAS® Tool Kit.

The storage case includes:

n Locator tool

n Adjustment tool

n Quick reference card

n Instructions for use

n X-ray overlay

n Spare batteries (CR123A)

n Screw driver



Codman® CERTAS™ Plus Electronic Tool KitA simplified Tool Kit that reduces post-operative reprogramming time.1

Codman CERTAS® Tool KitA versatile Tool Kit for non-invasive adjustment.

2 Locator Tools to accommodate different tissue thicknessesn The Adjustable Height Locator Tool provides freedom to select the optimal height so that the skin is just

below the valve cut-out.

n The Low Profile Locator Tool is for use when tissue thickness above the valve is greater than 10 mm or when edema is present. This tool has a flat bottom so it can sit flush against the skin.

Indicator Tool for valve setting readingn Provides rapid reading of the valve’s current performance setting.

n The position of the number in the window helps confirm that the tools are properly aligned with the valve.

Adjustment Tool for valve setting changen Provides an audible click and tactile response as you turn to each setting.

n Features a safety stop between settings 1 and 8.

The storage case includes:

n Adjustable height locator tool

n Low profile locator tool

n Indicator tool

n Adjustment tool

n Instructions for use

n X-ray overlay


SiphonGuard® Anti-Siphon DeviceControls the risk of overdrainage.

SiphonGuard® Anti-Siphon Device

The added safety of a pathway that remains openn Dual pathway, ball-and-spring anti-siphon device.

n During normal flow of CSF, both the primary and secondary pathways are open.

n The primary pathway closes when excessive flow is detected, while the secondary pathway remains open to decrease the drainage rate.

Designed to be unaffected by encapsulation, external pressure or deteriorating pliabilityn The rigid, polyethersulfone shell allows the SiphonGuard® Anti-Siphon Device to be impervious to conditions that

routinely cause silicone diaphragm device failure.1

n Its flow-sensing performance and durability are unaffected by scar tissue encapsulation or external pressures.1

n Its protected ball-and-spring design remains sensitive to differences between normal and excessive CSF flow.1



SiphonGuard® Anti-Siphon DeviceControls the risk of overdrainage.

Location independentn The SiphonGuard® Anti-Siphon Device may be placed in any orientation or location distal to any valve.2

Available in integrated or stand-alone configurations

n Available as an integral component of the Codman® CERTAS™ Plus Programmable Valve.

n The stand-alone device can be combined with any valve.

1. IKurtom K, Magram G. Siphon Regulatory Devices: Their Role in the Treatment of Hydrocephalus. Neurosurg Focus. 2007; 22(4):E5.2. Using the Codman HAKIM Programmable Valve with SiphonGuard Hashimoto, Mukai and Tsukada. The Neurosurgery Bulletin, Sept. 2004

Normal flow through open primary path (yellow)

During normal flow, ball is balanced off the seat

Secondary path (blue) is always open

1

1

3

3

2

2

4

6

7

5

Opening to enter secondary path is always open

During excessive flow, ball seats and closes primary path

Opening for flow to enter inner spiral of secondary path

Secondary path directs CSF through outer spiral to exit just below seated ball

7

5

6

4


Bactiseal® Antimicrobial Impregnated CatheterAn effective added precaution in the battle against shunt bacterial infection for more confidence.1

Clinically proven impregnated antimicrobial cathetern Proven to reduce shunt infection rates by over 60% across all age categories.4

n Reduces Gram positive bacterial colonization up to 50 days.1

n Proven to reduce the average total treatment costs per patient.2-4

n Generate budget savings of over £135,000 for every shunt infection avoided. 4

n Impregnated, not coated: continuous dual-drug protection on all catheter surfaces.1

n The combination of two antibiotics reduces the chance of developing resistance.1

n TK100 in less than 52 hours post implantation.1



Bactiseal® Antimicrobial Impregnated CatheterAn effective added precaution in the battle against shunt bacterial infection for more confidence.1

Bactiseal® Catheter3

Lumen surface of a Bactiseal® Catheter following two 14-day challenges in the in vitro model. No live bacteria are observed.

Control Catheter3

Coagulase-negative staphylococci on the surface of the lumen of an untreated control catheter in the in vitro model.

1. Bayston R, Ashraf W, Bhundia C. Mode of action of an antimicrobial biomaterial for use in hydrocephalus shunts. J. Antimicrobial Chemotherapy. 2004; 53:778-782. 2. Parker et al. Cerebrospinal shunt infection in patients receiving antibiotic-impregnated versus standard shunts. Journal of Neurosurgery: Pediatrics / Vol. 8, No.3: 259-265 / Sept. 20113. Codman in house testing reports, TR2213 and PVER99-133 Addendum. 4. Antibiotic or silver versus standard ventriculoperitoneal shunts (BASICS): a multicenter, single-blinded, randomized trial and economic evaluation. Mallucci CL, Jenkinson MD, Conroy EJ, et al. Lancet

2019, Published online Sept 12.

Creates Eliminates Protects

an effective barrier in reducing gram positive bacterial colonization on all catheter surfaces.1

100% (total time to kill)1 of all adhered bacteria in < 52 hours.

for up to 50 days with two, slow-release antibiotics, Rifampin and Clindamycin.1

Sales & Marketing EMEAIntegra LifeSciences Services (France) SAS Immeuble Séquoia 2 97 allée Alexandre Borodine n Parc technologique de la Porte des Alpes 69800 Saint Priest n France Phone: +33 (0)4 37 47 59 00 n +33 (0)4 37 47 59 99 (fax) integralife.eu

For more information or to place an order, please contact: Medos International SARLChemin-Blanc 38, 2400Le Locle i Suisse

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 indications, contraindications, hazards, warnings, precautions, and instructions for use.

Products mentioned in this document are CE class I, IIb and III devices. Contact Integra should you need any additional information on devices classification. All the medical devices mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.

SiphonGuard, Bactiseal, Codman, Codman Certas, Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. ©2019 Integra LifeSciences Corporation. All rights reserved. Last revision date: 12/2019. 1078572-3-EN. DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST and AFRICA ONLY.

IndicationsThe 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 and Codman® CERTAS™ Plus Electronic Tool Kit allow the noninvasive reading or adjustment of the valve setting.

ContraindicationsThese 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. The BACTISEAL Catheters are contraindicated in patients with known hypersensitivity to rifampin or clindamycin hydrochloride.

Catalog # Description Packaging

Regular

828800 Codman® CERTAS™ Plus Regular Valve Only 1

828801 Codman® CERTAS™ Plus Regular Valve System 1

828802 Codman® CERTAS™ Plus Regular Valve System Unitized 1

828803 Codman® CERTAS™ Plus Regular Valve System Unitized Bactiseal® 1

828804 Codman® CERTAS™ Plus Regular Valve Only with SiphonGuard® 1

828805 Codman® CERTAS™ Plus Regular Valve System with SiphonGuard® 1

828806 Codman® CERTAS™ Plus Regular Valve System Unitized with SiphonGuard® 1

828807 Codman® CERTAS™ Plus Regular Valve System Unitized Bactiseal® with SiphonGuard® 1

Small

828810 Codman® CERTAS™ Plus Small Valve Only 1

828811 Codman® CERTAS™ Plus Small Valve System 1

828812 Codman® CERTAS™ Plus Small Valve System Unitized 1

828813 Codman® CERTAS™ Plus Small Valve System Unitized Bactiseal® 1

828814 Codman® CERTAS™ Plus Small Valve Only with SiphonGuard® 1

828815 Codman® CERTAS™ Plus Small Valve System with SiphonGuard® 1

828816 Codman® CERTAS™ Plus Small Valve System Unitized with SiphonGuard® 1

828817 Codman® CERTAS™ Plus Small Valve System Unitized Bactiseal® with SiphonGuard® 1

Right Angle

828820 Codman® CERTAS™ Plus Right Angle Valve Only 1

828821 Codman® CERTAS™ Plus Right Angle Valve System 1

828822 Codman® CERTAS™ Plus Right Angle Valve System Unitized 1

828823 Codman® CERTAS™ Plus Right Angle Valve System Unitized Bactiseal® 1

828824 Codman® CERTAS™ Plus Right Angle Valve Only with SiphonGuard® 1

828825 Codman® CERTAS™ Plus Right Angle Valve System with SiphonGuard® 1

828826 Codman® CERTAS™ Plus Right Angle Valve System Unitized with SiphonGuard® 1

828827 Codman® CERTAS™ Plus Right Angle Valve System Unitized Bactiseal® with SiphonGuard® 1

Tool Kits

828852 Codman® CERTAS™ Plus Electronic Tool Kit 1

828851 Codman CERTAS® Tool Kit 1

Ordering Information

Customer ServicesInternational: +33 (0) 437 47 59 50 n +33 (0) 437 47 59 25 (Fax) n [email protected]: +33 (0) 437 47 59 10 n +33 (0) 437 47 59 29 (Fax) n [email protected] Kingdom: +44 (0) 1264 312 725 n +44 (0) 1264 312 821 (Fax) n [email protected]: +353 1800 901567 n +353 1822 5952 (Fax) n [email protected]: +49 (0) 2102 5535 6200 n +49 (0) 2102 5536 636 (Fax) n [email protected]: +43(0)720816067 n +43(0)19287201 n [email protected]: +39 (0)2 577 89 21 n +39 (0)2 575 113 71 (Fax) n [email protected] & Luxembourg: +32 (0)2 257 4130 n +32 (0)2 253 2466 (Fax) n [email protected] Switzerland: +41 (0)2 27 21 23 00 n +41 (0)2 27 21 23 99 (Fax) n [email protected]: +31(0)852083167 n +31(0)207093627 n [email protected]

Provides the exibility, simplicity, control and con dence to ...app.sales.integralife.com/csf-management/programmable...No live bacteria are observed. Control Catheter3 Coagulase-negative

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