Download salesheet Integra Regulated Flow solutions

ENG
Integra
®
Regulated Flow with
OSV II™, OSV II Low Pro™,
Integra® NPH Low Flow valves
Simplify your choices
with a smart shunt solution
Products for sale in Europe, Middle-East and Africa only
Integra®
Regulated Flow with OSV II™, OSV II Low Pro™, Integra® NPH Low Flow valves
Indications / Contraindications
OSV II™ Valve System
OSV II Low Pro™ Valve
Integra® NPH Low Flow Valve
Introduced in 1987, the Orbis-Sigma
Valve was the first valve to manage
hydrocephalus through flow-regulation
rather than conventional differentialpressure regulation. The valve operates a
3-stage, variable resistance mechanism
that regulates flow through the valve
(Stage II) at a rate close to that of CSF
secretion (around 20 ml/h). The OSV II™
Valve delivers position-independent
performance, without programming or
frequent adjustments.
OSV II Low Pro™ Valve utilizes the SelfAdjusting technology in a lower profile
design to suit the needs of various
patient populations. The OSV II Low Pro™
Valve delivers position-independent
performance, without programming
or frequent adjustments.
The Integra® NPH Low Flow Valve delivers
position-independent
performance,
without programming or frequent
adjustments. It is designed for patients
who require a reduced drainage of 10
ml/h.
Indications For Use
The OSV II™ Valve System is
an implantable system used in
the treatment of patients with
hydrocephalus, to shunt CSF from the
ventricles to the peritoneal cavity or
other appropriate drainage site such as
the heart’s right atrium.
Contraindications
This valve system should not
be implanted when an infection
along the shunt pathway (e.g.
meningitis, ventriculitis, peritonitis,
septicemia, bacteremia) is suspected.
It is advisable to postpone valve
implantation if an infection is
present anywhere in the body. Atrial
shunting is not advised for patients
with congenital heart disease or
other serious cardiopulmonary
abnormalities.
The OSV II™ Valve System should
not be implanted in patients with
untreated choroid plexus tumors.
Such tumors produce CSF at rates in
excess of the specification of the flow
regulation Stage II, and the OSV II™
Valve System would underdrain under
these conditions.
The OSV II™ Valve System should
not be used for drainage of
extraventricular fluid collections such
as hygromas or cysts; such conditions
are typically treated with very low
differential pressure valves.
1
Indications For Use
The OSV II Valve System is
an implantable system used in
the treatment of patients with
hydrocephalus, to shunt CSF from the
ventricles to the peritoneal cavity or
other appropriate drainage site such as
the heart’s right atrium.
™
Contraindications
This valve system should not
be implanted when an infection
along the shunt pathway (e.g.
meningitis, ventriculitis, peritonitis,
septicemia, bacteremia) is suspected.
It is advisable to postpone valve
implantation if an infection is
present anywhere in the body. Atrial
shunting is not advised for patients
with congenital heart disease or
other serious cardiopulmonary
abnormalities.
The OSV II™ Valve System should
not be implanted in patients with
untreated choroid plexus tumors.
Such tumors produce CSF at rates in
excess of the specification of the flow
regulation Stage II, and the OSV II™
Valve System would underdrain under
these conditions.
The OSV II™ Valve System should
not be used for drainage of
extraventricular fluid collections such
as hygromas or cysts; such conditions
are typically treated with very low
differential pressure valves.
Indications For Use
The Integra® NPH Low Flow Valve
is an implantable system used in
the treatment of patients with
hydrocephalus, to shunt CSF from the
ventricles to the peritoneal cavity or
other appropriate drainage site such as
the heart’s right atrium.
Contraindications
This valve system should not
be implanted when an infection
along the shunt pathway (e.g.
meningitis, ventriculitis, peritonitis,
septicemia, bacteremia) is suspected.
It is advisable to postpone valve
implantation if an infection is
present anywhere in the body. Atrial
shunting is not advised for patients
with congenital heart disease or
other serious cardiopulmonary
abnormalities. Integra® NPH Low
Flow Valve should not be implanted
in patients with untreated choroid
plexus tumors. Such tumors
produce CSF at rates in excess of the
specification of the flow regulation
Stage II, and the valve would
underdrain under these conditions.
Integra® NPH Low Flow Valve
should not be used for drainage of
extraventricular fluid collections such
as hygromas or cysts; such conditions
are typically treated with very low
differential pressure valves
Brochure Regulated Flow OSV II™, OSV II Low Pro™, Integra® NPH Low Flow valves
Products for sale in Europe, Middle-East and Africa only.
Integra®
Regulated Flow with OSV II™, OSV II Low Pro™, Integra® NPH Low Flow valves
3 Steps Flow Regulation
OSV II™ / OSV II Low Pro™
Integra® NPH Low Flow Valve
Differential Pressure (mm H2O)
STAGE I – 30-120 mm H2O
Differential Pressure (DP) Valve
This stage begins when the flow rate reaches 5ml/h.
III
400
III
300
II
200
100
I
0
II
I
5
10
20
Flow Rate (ml/h)
o™
II ™
Pr
w
OS
V
Lo
II
V
Maintains a close
balance between CSF
flow and production
rate, restricting flow
around 10 ml/h,
whatever the differential
pressure is.
OS
In
te
g
Fl ra ®
ow N
Va PH
lv Lo
e w
STAGE II – 120-300 mm H2O
Flow Regulating Valve
STAGE III – Above 300 mm H2O
Safety Valve
Immediately restores normal ICP during unexpected pressure elevation. Rarely needed.
4
Brochure Regulated Flow OSV II™, OSV II Low Pro™, Integra® NPH Low Flow valves
Products for sale in Europe, Middle-East and Africa only.
Maintains a close
balance between CSF
flow and production
rate, restricting flow
around 20 ml/h,
whatever the differential
pressure is.
40
Integra®
Regulated Flow with OSV II™, OSV II Low Pro™, Integra® NPH Low Flow valves
your choices
with a smart shunt solution
SIMPLIFY your shunt choice
ɈɈ ONE SIZE
for PAEDIATRICS AND ADULTS under 60 years old (OSV II™ valve)
ɈɈ Flow Regulated Shunt mechanism designed to
MANAGE VASOGENIC AND POSTURAL DAILY PRESSURE CHANGES4,8
ɈɈ NO FURTHER SETTING ADJUSTMENT
needed as self-adjusting
ɈɈ NO NEED TO FIND
the right PROGRAMMER in EMERGENCY CASES
SIMPLIFY your setting choices
ɈɈ NO NEED TO SELECT ANY PRESSURE SETTING
(thanks to Flow Regulated mechanism)
ɈɈ NO NEED TO ADD a Gravity Compensating
Accessory (GCA) or Anti-Siphon Device (ASD)4
ɈɈ NO NEED TO CHANGE GCA/ASD
when the patient grows up4
SIMPLIFY your shunt placement
ɈɈ Free shunt placement as NO DIAGNOSTIC IMAGE DISTORTION with FR shunts4
ɈɈ NO RESTRICTION OF PLACEMENT (no need to position at 0 level as for ASD)4
ɈɈ Can be placed in VENTRICULAR OR LUMBAR regions without any
restriction (ASD need to be placed in ventricular region)4
ɈɈ Flow Regulated shunts DON’T NEED TO BE PLACED VERTICALLY compared to GCA4
SIMPLIFY your surgical technique
ɈɈ FEW CONNECTIONS
as hydrostatic management device is part of the valve design1,3,4
ɈɈ Many CONFIGURATIONS AVAILABLE to fit your patients
needs (1, 2 or 3 piece(s), Burr Hole, Lumbar)
For complete product information, please see the Instructions for Use accompanying each product.
Brochure Regulated Flow OSV II™, OSV II Low Pro™, Integra® NPH Low Flow valves
Products for sale in Europe, Middle-East and Africa only.
5
Integra®
Regulated Flow with OSV II™, OSV II Low Pro™, Integra® NPH Low Flow valves
SIMPLIFY your patient management
ɈɈ BETTER OVERALL SHUNT SURVIVAL RATE
(62% at 5 years1 compared to 53.1% for programmable shunts2)
ɈɈ LIMIT OVERDRAINAGES
as Flow Regulated manages both postural & vasogenic events1,3,7:
overdrainage complication rate from 2.6% to 9.8% for DP & from 0% to 2% for Flow Regulated
ɈɈ REDUCE MECHANICAL COMPLICATION RISK
due to hydrodynamic properties of shunt (overdrainage, underdrainage & late obstruction):
22% for DP compared to 5% for FR shunts at 1 year3
ɈɈ REDUCE SLITLIKE VENTRICLES
10.8% for DP, 10.5% for Delta & 3.6% for Flow Regulated5
ɈɈ NO ASD RELATED COMPLICATIONS
SIMPLIFY the mri environment management
ɈɈ NO IMAGE DISTORTION
as no metal component4
ɈɈ
Lo
ɈɈ NO NEED OF SYSTEMATIC CONTROL
after MRI procedure
NO GCA NEEDED
In
II
V
OS
OS
V
w
II ™
Pr
o™
ɈɈ
NO RISK OF PRESSURE SETTING CHANGES
by MRI or strong magnetic field as no metal component4,6
(MRI caused resetting in 26.8% of cases
with DP programmable shunts2)
te
g
F l r a®
ow N
Va PH
lv Lo
e w
OSV II Low Pro™
OSV II™
Integra® NPH
Low Flow valves
your choices
with a smart shunt solution
Brochure Regulated Flow OSV II™, OSV II Low Pro™, Integra® NPH Low Flow valves
Products for sale in Europe, Middle-East and Africa only.
6
Integra®
Regulated Flow with OSV II™, OSV II Low Pro™, Integra® NPH Low Flow valves
your choices
with a smart shunt solution
Product References
OSV II™ Valve Unit
With Antechamber
Without Antechamber
909700
909701
OSV II™
OSV II Low Pro™ Valve Unit
With Low Profile Antechamber and integral connectors
909700P
OSV II Low Pro™
Integra® NPH Low Flow Valve, Valve Unit
With Antechamber
Without Antechamber
909500
909501
Integra® NPH Low
Flow Valve
Download our complete CSF product catalogue by
using this QR Code with your SmartPhone 
References
1.
Hanlo PW, Cinalli G, Vandertop WP, Faber JA, Bogeskov L, Borgesen SE, Boschert J, Chumas P, Eder H, Pople IK, Serlo W, Vitzthum E.
Treatment of hydrocephalus determined by the European Orbis Sigma Valve II survey: a multicenter prospective 5-year shunt survival study in children and adults in whom a flowregulating shunt was used.
J Neurosurg 2003;99(1):52-7.
2. Zemack G, Romner B.
Seven years of clinical experience with the programmable Codman Hakim valve: a retrospective study of 583 patients.
J Neurosurg 2000;92(6):941-8.
3.
Decq P, Barat JL, Duplessis E, Leguerinel C, Gendrault P, Keravel Y.
Shunt failure in adult hydrocephalus: flow-controlled shunt versus differential pressure shunts--a cooperative study in 289 patients.
Surg Neurol 1995;43(4):333-9.
4. Technical file & IFU
5. Kan P, Walker ML, Drake JM, Kestle JR.
Predicting slitlike ventricles in children on the basis of baseline characteristics at the time of shunt insertion.
J Neurosurg 2007;106(5 Suppl):347-9.
6. Czosnyka M, Czosnyka Z, Whitehouse H, Pickard JD.
Hydrodynamic properties of hydrocephalus shunts: United Kingdom Shunt Evaluation Laboratory.
J Neurol Neurosurg Psychiatry 1997;62(1):43-50.
7.
Drake JM, Kestle JR, Milner R, Cinalli G, Boop F, Piatt J, Jr., Haines S, Schiff SJ, Cochrane DD, Steinbok P, MacNeil N.
Randomized trial of cerebrospinal fluid shunt valve design in pediatric hydrocephalus.
Neurosurgery 1998;43(2):294-303.
8. Sainte-Rose C, Hooven MD, Hirsch JF.
A new approach in the treatment of hydrocephalus.
J Neurosurg 1987;66(2):213-26.
Integra LifeSciences Services (France) SAS
Sales & Marketing EMEA
Immeuble Séquoia 2 97 allée Alexandre Borodine
Parc technologique de la Porte des Alpes
69800 Saint Priest FRANCE
Phone: +33 (0)4 37 47 59 00 Fax: +33 (0)4 37 47 59 99
[email protected] integralife.eu
Customer Service
International : +33 (0)4 37 47 59 50 +33 (0)4 37 47 59 25 (Fax) [email protected]
Royaume-Uni : +44 (0)1 264 345 780 +44 (0)1 264 363 782 (Fax) [email protected]
France : +33 (0)4 37 47 59 10 +33 (0)4 37 47 59 29 (Fax) [email protected]
Benelux : +32 (0)2 257 4130 +32 (0)2 253 2466 (Fax) [email protected]
Suisse : +41 (0)2 27 21 23 30 +41 (0)2 27 21 23 99 (Fax) [email protected]
Integra NeuroSciences Implants (France) S.A.S.
2905 route des dolines
06921 Sophia Antipolis Cedex FRANCE
©2013 Integra LifeSciences Corporation. All rights reserved. ILS 06-01-010-01-13
PRODUCTS FOR SALE IN EUROPE, MIDDLE-EAST and AFRICA ONLY
Distributed by
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. Always refer to the appropriate instructions for use for complete clinical instructions. Non
contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.
WARNING: Applicable laws restrict these products to sale by or on the order of a physician. All text and diagrams contained in this catalog are
intended as guidelines and are for illustrative purposes only. No information included in this catalog is intended to replace the Directions for
Use packaged with each Integra product. Always refer to the appropriate Directions for Use for complete clinical instructions. For technical
and additional clinical information on Integra products, please contact your Integra local sales representative. OSV II and OSV II Low Pro are
trademarks of Integra LifeSciences Corporation or its subsidiaries. Integra and the Integra logo are registered trademarks of Integra Lifesciences
Corporation in the United States and/or other countries. All the references numbers 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.” Devices listed in
this document are Class I, IIa, IIb and III Medical Devices. Please contact your Integra customer service representative for more information on
the devices classification.