Flow Regulated Valves OSV II™
Limits uncertainty by automatically adjusting to the patient’s changing need.
OSV II™ valves simplify:
Your shunt choice:
- Only 2 drainage rates for the whole population.
- No further setting adjustment needed as it automatically adjusts to the patient’s needs to maintain a physiological flow rate.
- No need to add accessories such as anti-siphon devices.
- No need to find the right programmer in emergency cases.
Your patient management:
- Better overall shunt survival rate 62% at 5 years 1 compared to 53.1% for programmable shunts.2
- Limit overdrainages as flow regulated shunts manage both postural & vasogenic events.1,3,6
- Reduce slitlike ventricles 10.8% for DP, 10.5% for Delta & 3.6% for Flow Regulated.5
- No significant image distortion in MRI thanks to constitutive materials.4
Integra OSV II® Valve System
- Flow Rate: 18-30 ml/hr.
- Size: 40.5 mm (L) x 12.5 mm (W) x 7.9 mm (H)
Integra OSV II Low Pro™ Valve System
Lower profile than the OSV II® Valve system accommodates patients with thin skin:
- Flow Rate: 18-30 ml/hr
- Size: 36 mm (L) x 12.5 mm (W) x 5.8 mm (H)
See Instructions For Use for complete product information.
Integra® Flow Regulating Low Flow Valve Systems
Accommodates patients with lower than average CSF flow:
- Flow Rate: 8-17 ml/hr
- Size: 40.5 mm (L) x 12.5 mm (W) x 7.9 mm (H)
Integra Flow Regulating Valve Low Flow, Mini
Lower profile than Integra Flow Regulating Valve Low Flow Standard, and low flow rate to accommodate patients with lower than average CSF flow and that have thin skin:
- Flow Rate: 8-17 ml/hr
- Size: 36 mm (L) x 12.5 mm (W) x 5.8 mm (H)
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 flow-regulating 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. Instructions for use Integra OSV II™ page 8, version BL515010 Rev 02
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. 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):294-303.2. Product considered MR conditional (for more information please consult the instructions for use)
Indications
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.
The OSV II Lumbar Valve System is an implantable system used in the treatment of patients with communicating hydrocephalus to shunt CSF from the lumbar subarachnoid region to the peritoneal cavity.
Contraindications
This valve system should not be implanted when an infection along the shunt pathway (e.g. meningitis, ventriculitis, peritonitis) is suspected. It is advisable to postpone valve implantation if an infection is present anywhere in the body (septicemia, bacteremia). Atrial shunting is not advised for patients with congenital heart disease or other serious cardiopulmonary abnormalities.
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.
The OSV II Valve System and Lumbar 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 and Lumbar Valve System would underdrain under these conditions. The OSV II Lumbar Valve System should not be used in patients with non-communicating hydrocephalus.
Ordering Information
Flow Regulated valves
| Catalogue Number | Description |
|---|---|
| 909700 | OSV II™ Valve Unit, with Antechamber |
| 909701 | OSV II™ Valve Unit, without Antechamber |
| 909704 | OSV II™ Shunt System, One-Piece, 13cm Ventricular Catheter, with Antechamber |
| 909705 | OSV II™ Shunt System, One-Piece, 9cm Ventricular Catheter, without Antechamber |
| 909706 | OSV II™ Shunt System, One-Piece, 9cm Ventricular Catheter, with Antechamber |
| 909707 | OSV II™ Shunt System, Two-Piece, 65cm Tunneler, with Antechamber |
| 909707S | OSV II™ Shunt System, Two-Piece, with Antechamber |
| 909708 | OSV II™ Shunt System, Two-Piece, 65cm Tunneler, without Antechamber |
| 909708S | OSV II™ Shunt System, Two-Piece, without Antechamber |
| 909710 | OSV II™ Lumbo Peritoneal Shunt System, Two-Piece, without Antechamber |
| 909711 | OSV II™ Lumbo Peritonea lShunt System, Two-Piece, with Antechamber |
| 909712 | OSV II™ Shunt System, Two-Piece, 15 cm Ventricular Catheter, with Antechamber |
| 909713 | OSV II™ Shunt System, Two-Piece, 15 cm Ventricular Catheter, without Antechamber |
| 909714 | OSV II™ Shunt System, Two-Piece, 15 cm Ventricular Catheter, 65cm Tunneler, with Antechamber |
| 909715 | OSV II™ Shunt System, Two-Piece, 15 cm Ventricular Catheter, 65cm Tunneler, without Antechamber |
| 909718 | OSV II™ Shunt System, One-Piece, 7cm Ventricular Catheter, with Antechamber |
| 909719 | OSV II™ Shunt System, One-Piece, 7cm Ventricular Catheter, without Antechamber |
| 909720 | OSV II™ Burr-Hole System, Two-Piece, 15 cm Ventricular Catheter, without Antechamber |
| 909721 | OSV II™ Burr-Hole System, Two-Piece, 15 cm Ventricular Catheter, with Antechamber |
| 909700P | OSV II Low Pro™ Valve only |
| 909712P | OSV II Low Pro™ Shunt System, Two-Piece, 15 cm Ventricular Catheter, with Antechamber |
| 9OS712 | OSV II™ 2 piece system with antechamber, F8 striped ventricularcatheter w/non radiopaque length markers |
| 9OS721 | OSV II™ 2 piece system, Burr-Hole system with antechamber, F8 striped ventricular catheter w/non radiopaque length markers |
Integra Low Flow Valves
| Catalogue Number | Description |
|---|---|
| 909500 | Standard, Valve Unit with Antechamber |
| 909501 | Standard, Valve Unit without Antechamber |
| 909506 | Standard, Shunt System, One-Piece, 9 cm Ventricular Catheter, with Antechamber |
| 909510 | Lumbar, Shunt System, Two-Piece, without Antechamber |
| 909512 | Standard, Shunt System, Two-Piece, 15 cm Ventricular Catheter, with Antechamber |
| 909513 | Standard, Shunt System, Two-Piece, 15 cm Ventricular Catheter, without Antechamber |
| 909514 | Standard, Shunt System, Two-Piece, 15 cm Ventricular Catheter, Tunneler, with Antechamber |
| 909520 | Standard, Burr Hole Shunt System, Two-Piece, 15 cm Ventricular Catheter, without Antechamber |
| 909521 | Standard, Burr Hole Shunt System, Two-Piece, 15 cm Ventricular Catheter, with Antechamber |
| 909507S | Standard, Shunt System, Two-Piece, with Antechamber |
| 909508S | Standard, Shunt System, Two-Piece, without Antechamber |
| 9OS512 | Standard, 2 piece system with antechamber, F8 striped ventricular actheter w/non radiopaque length markers |
| 9OS521 | Standard, 2 piece burr hole system with antechamber, F8 striped ventricular catheter w/non radiopaque length markers |
| 909500P | Mini, Valve unit with low profile antechamber |
| 909512P | Mini, Two piece system: valve with low profile antechamber Separate 15cm ventricular catheter |
| 9OS512P | Mini, Two piece system: valve with low profile antechamber, Integral 110cm distal catheter, Separate F8 striped ventricular catheter w/non radiopaque length markers |
Product Catalogues
Regulatory Information
Class III Medical Devices
Integra NeuroSciences Implants (France) S.A.S.
2905 route des dolines
06921 Sophia Antipolis Cedex • FRANCE
No EC REP
Legal information
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.
• Consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions and instructions for use.
• Non contractual document. Integra 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.
Products mentioned in this document are CE class III devices. Please contact Integra customer service 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.”
OSV II, 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.
© 2016 Integra LifeSciences Corporation. All rights reserved. Last revision date: 12/2016. 0535105-2-EN
Document for use in Europe, Middle-East & Africa only
For complete product information, please consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions, and instructions for use.
