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Aesculap Neurosurgery proGAV ® 2.0 Rx Only Simplicity. Comfort. Protection.
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Rx Only Simplicity. Comfort. Protection.3 Allin DM, Czosnyka ZH, Czosnyka M, Richards HK, Prickard JD. In vitro hydrodynamic properties of the Miethke proGAV hydrocephalus shunt. ...

Mar 14, 2020

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Page 1: Rx Only Simplicity. Comfort. Protection.3 Allin DM, Czosnyka ZH, Czosnyka M, Richards HK, Prickard JD. In vitro hydrodynamic properties of the Miethke proGAV hydrocephalus shunt. ...

Aesculap Neurosurgery

proGAV ® 2.0Rx OnlySimplicity. Comfort. Protection.

Page 2: Rx Only Simplicity. Comfort. Protection.3 Allin DM, Czosnyka ZH, Czosnyka M, Richards HK, Prickard JD. In vitro hydrodynamic properties of the Miethke proGAV hydrocephalus shunt. ...

2

proGAV 2.0®

In touch with you

MIETHKE Gravitational Valves provide a new solution for drainage control in offering the latest advancement in the treatment of Hydrocephalus. proGAV 2.0 provides the reliability of our existing valves1, 2, 3

with new features to ensure simplicity for the surgeon, with comfort and protection for the patient.

proGAV ® 2.0

Simplicity. Comfort. Protection.

Tactile feedback

MR Conditional to 3T or less*

Gravitational unit

Simplicity.■ 3-Step Reprogramming offers an easy solution if adjustment to the pressure setting is necessary

■ Tactile “feedback mechanism” provides confidence that the adjustment has been made

* Please refer to the MRI Safety Information section of the Instructions for Use for MR-related safety information.

*See Indications for Use on back cover.

Page 3: Rx Only Simplicity. Comfort. Protection.3 Allin DM, Czosnyka ZH, Czosnyka M, Richards HK, Prickard JD. In vitro hydrodynamic properties of the Miethke proGAV hydrocephalus shunt. ...

3

“Soft touch” Instrumentation

Comfort.■ “Soft Touch” technology provides protection against painful readjustments

■ 0 – 20 cm H2O Pressure settings allow for a custom approach and a wide range of treatment options

Protection.■ Gravitational technology provides the latest advancement in Hydrocephalus drainage control

■ “Active Lock” mechanism provides security against inadvertent readjustment caused by MRI 3 Tesla or less

1 Thomale UW, Gerbert AF, Haberl H, Schulz M. Shunt survival rates by using the adjustable differential pressure valve combined with a gravitational unit (proGAV) in pediatric neurosurgery. Childs Nerv Syst. 2013 Mar;29(3):425-31.

2 Lemcke J, Meier U, Müller C, Fritsch MJ, Kehler U, Langer N, Kiefer M, Eymann R, Schuhmann MU, Speil A, Weber F, Remenez V, Rohde V, Ludwig HC, Stengel D. Safety and efficacy of gravitational shunt valves in patients with idiopathic normal pressure hydrocephalus: a pragmatic, randomised, open label, multicentre trial (SVASONA). J Neurol Neurosurg Psychiatry. 2013 Aug;84(8):850-57.

3 Allin DM, Czosnyka ZH, Czosnyka M, Richards HK, Prickard JD. In vitro hydrodynamic properties of the Miethke proGAV hydrocephalus shunt. Cerebrospinal Fluid Res. 2006 Jun;3:9.

Page 4: Rx Only Simplicity. Comfort. Protection.3 Allin DM, Czosnyka ZH, Czosnyka M, Richards HK, Prickard JD. In vitro hydrodynamic properties of the Miethke proGAV hydrocephalus shunt. ...

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proGAV ® 2.0

Reprogramming Instruments

VerifyPlace the Compass over the valve. Open the lid and align the valve with the internal template. Close the lid and the current setting will be reflected in the window.

1

AdjustRemove the compass and position the Adjustment Tool over the valve so that the desired setting is in line with the reservoir or proximal catheter. Press gently in the center of the valve until a tactile click occurs.

2

Compass

The proGAV 2.0 Compass can be used to locate and verify the current setting of the valve.

3-Step Reprogramming

Page 5: Rx Only Simplicity. Comfort. Protection.3 Allin DM, Czosnyka ZH, Czosnyka M, Richards HK, Prickard JD. In vitro hydrodynamic properties of the Miethke proGAV hydrocephalus shunt. ...

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Adjustment tool

The proGAV ® 2.0 Adjustment Tool allows for an adjustment to the opening pressure (0 to 20 cm H2O).

VerifyPlace the Compass over the valve. Open the lid and align the valve with the internal template. Close the lid and the new setting will be reflected in the window. Verification may be confirmed by radiograph (x-ray).

3

Page 6: Rx Only Simplicity. Comfort. Protection.3 Allin DM, Czosnyka ZH, Czosnyka M, Richards HK, Prickard JD. In vitro hydrodynamic properties of the Miethke proGAV hydrocephalus shunt. ...

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proGAV ® 2.0

How the valve works The proGAV 2.0 is a position-dependent valve, meaning the opening pressure changes gradually corresponding to the patient’s body position. proGAV 2.0 allows for complete customization of the patient’s needs in allowing for a specific opening pressure when the patient is lying down, and a specific opening pressure for when the patient is upright.

Gravitational unit

The adjustable unit can be set in increments of 1 cm H2O between 0 and 20 cm H2O.

Adjustable unit

The gravitational unit is available in various pressure settings.

Optimized rotor design

“Active Lock” MR brake 3T or lessProtective

titanium housing

Low profile design

Page 7: Rx Only Simplicity. Comfort. Protection.3 Allin DM, Czosnyka ZH, Czosnyka M, Richards HK, Prickard JD. In vitro hydrodynamic properties of the Miethke proGAV hydrocephalus shunt. ...

7

“The free Miethke app for Apple and Android simply explains the functionality of all Miethke gravitational valves.”

Technology

Horizontal positionWhen the patient is in the supine position, only the adjustable unit is active and preset to 5 cm H2O*. The gravitational unit is not active in this body position.

Vertical positionIn the upright position, the gravitational and adjustable units work together. As the patient sits up, the tantalum ball (green) is activated within the gravitational unit and causes an increase in the opening pressure.

The gradual increase in opening pressure in the upright position effectively protects against excessive drainage.

In the example shown, a gravitational unit with 25 cm H2O has been selected. Therefore the total opening pressure equals 30 cm H2O** when in the upright position.

Active

Inactive20

0

45

25

30

15° 30° 45° 60° 75° 90°5

Valv

e op

enin

g pr

essu

re in

cm

H2O

*

**

Page 8: Rx Only Simplicity. Comfort. Protection.3 Allin DM, Czosnyka ZH, Czosnyka M, Richards HK, Prickard JD. In vitro hydrodynamic properties of the Miethke proGAV hydrocephalus shunt. ...

8

proGAV ® 2.0

Pressure SelectionSome considerations for proGAV 2.0 pressure selection include patient height, weight, activity level, medical condition and age. The opening pressure of the adjustable valve can be set to a value between 0 and 20 cm H2O depending on the patient’s clinical presentation and indication.

Please refer to the product Instructions for Use for more information.

■ The gravitational unit is available in 6 pressures, from 10-35 cm H2O in increments of 5 cm H2O.

■ The taller the patient, the higher the pressure level of the gravitational unit.

■ The shorter the patient or more overweight, the lower the pressure level of the gravitational unit.

■ The more immobile the patient, the lower the pressure level of the gravitational unit.

The pressure of the shunt system in the supine position is maintained by the setting of the adjustable valve only. In the upright position, the pressure is the total of the adjustable valve pressure and the pressure of the gravitational unit.

See the Pressure Recommendation Chart available as a download from www.aesculapusa.com

Recommended settings only; may vary according to patient and medical history.

ADJUSTABLE VALVE

p p p

Standard (children, NPH patients)

5 cm H2O

10 cm H2O

15 cm H2O

Defensive (patients with extremely wide ventricles and highly elevated ICP or aqueductal stenosis)

Special (patients with pseudotumor cerebri)

Patient Type Recommended Setting

Page 9: Rx Only Simplicity. Comfort. Protection.3 Allin DM, Czosnyka ZH, Czosnyka M, Richards HK, Prickard JD. In vitro hydrodynamic properties of the Miethke proGAV hydrocephalus shunt. ...

9

X-ray VerificationThe setting of the proGAV ® 2.0 valve can be easily identified on post-operative x-rays by placing an x-ray template (supplied) over the radiographic image.

NOTE: The orientation indicator should face three o’clock to maintain the correct position. In the event the image is reversed, simply flip the template over.

A triangle is formed by visually connecting the magnets and drill holes. The sharp corner of the triangle indicates the position of the rotor tip. The direction of the rotor tip indicates the pressure setting of the valve.

Children up to 5 years 20 cm H20

25 cm H20

20 cm H20

Children over 5 years Adults up to 60 years

Adults over 60 years

Patient Type Recommended Valve

GRAVITATIONAL UNIT

cmH20

642

0

8

10

12

141618

20

range not

adjustable

triangle tip

orientation indicatorinlet indicator

proGAV 2.0

Coding for inlet

Rotor coding

Magnets

Orientation indicator

Virtual triangle

Recommended settings only; may vary according to patient and medical history.

Page 10: Rx Only Simplicity. Comfort. Protection.3 Allin DM, Czosnyka ZH, Czosnyka M, Richards HK, Prickard JD. In vitro hydrodynamic properties of the Miethke proGAV hydrocephalus shunt. ...

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proGAV ® 2.0

Instruments

proGAV ® 2.0 Adjustment tool proGAV ® 2.0 Compass

proGAV ® Checkmate*

*Ordered separately

Article No. Tools

FX400T proGAV ® 2.0 adjustment tool

FX401T proGAV ® 2.0 compass

FV403T proGAV ® compass

FV407T proGAV ® adjustment disc

FV409T proGAV ® checkmate*

proGAV ® Compass*proGAV ® Adjustment disc*

Page 11: Rx Only Simplicity. Comfort. Protection.3 Allin DM, Czosnyka ZH, Czosnyka M, Richards HK, Prickard JD. In vitro hydrodynamic properties of the Miethke proGAV hydrocephalus shunt. ...

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Notes

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Page 12: Rx Only Simplicity. Comfort. Protection.3 Allin DM, Czosnyka ZH, Czosnyka M, Richards HK, Prickard JD. In vitro hydrodynamic properties of the Miethke proGAV hydrocephalus shunt. ...

Aesculap, Inc. | 3773 Corporate Parkway | Center Valley, PA | 18034Phone 800-282-9000 | Fax 610-791-6886 | www.aesculapusa.com

Aesculap, Inc. - a B. Braun company

All rights reserved. Technical alterations are possible. This leaflet may be used for no other purposes than offering, buying and selling of our products. No part may be copied or reproduced in any form. In the case of misuse we retain the rights to recall our catalogs and price lists and to take legal actions.

©2017 AESCULAP. ALL RIGHTS RESERVED. PRINTED IN THE USA.Aesculap is an equal opportunity employer

DOC1186 Rev. A 1M 5/17

INDICATIONS FOR USE: The Miethke proGAV ® 2.0 Adjustable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the

lateral ventricles of the brain to the peritoneum. See Instructions for Use for additional information including Warnings and Precautions. Rx only.