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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)

OSVII-Labeled copie


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)

osvII low pro
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)

NPH_path


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)

NPH Low Pro_0104_clipping

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 NumberDescription
909700OSV II™ Valve Unit, with Antechamber
909701OSV II™ Valve Unit, without Antechamber
909704OSV II™ Shunt System, One-Piece, 13cm Ventricular Catheter, with Antechamber
909705OSV II™ Shunt System, One-Piece, 9cm Ventricular Catheter, without Antechamber
909706OSV II™ Shunt System, One-Piece, 9cm Ventricular Catheter, with Antechamber
909707OSV II™ Shunt System, Two-Piece, 65cm Tunneler, with Antechamber
909707SOSV II™ Shunt System, Two-Piece, with Antechamber
909708OSV II™ Shunt System, Two-Piece, 65cm Tunneler, without Antechamber
909708SOSV II™ Shunt System, Two-Piece, without Antechamber
909710OSV II™ Lumbo Peritoneal Shunt System, Two-Piece, without Antechamber
909711OSV II™ Lumbo Peritonea lShunt System, Two-Piece, with Antechamber
909712OSV II™ Shunt System, Two-Piece, 15 cm Ventricular Catheter, with Antechamber
909713OSV II™ Shunt System, Two-Piece, 15 cm Ventricular Catheter, without Antechamber
909714OSV II™ Shunt System, Two-Piece, 15 cm Ventricular Catheter, 65cm Tunneler, with Antechamber
909715OSV II™ Shunt System, Two-Piece, 15 cm Ventricular Catheter, 65cm Tunneler, without Antechamber
909718OSV II™ Shunt System, One-Piece, 7cm Ventricular Catheter, with Antechamber
909719OSV II™ Shunt System, One-Piece, 7cm Ventricular Catheter, without Antechamber
909720OSV II™ Burr-Hole System, Two-Piece, 15 cm Ventricular Catheter, without Antechamber
909721OSV II™ Burr-Hole System, Two-Piece, 15 cm Ventricular Catheter, with Antechamber
909700POSV II Low Pro™ Valve only
909712POSV II Low Pro™ Shunt System, Two-Piece, 15 cm Ventricular Catheter, with Antechamber
9OS712OSV II™  2 piece system with antechamber, F8 striped ventricularcatheter w/non radiopaque length markers
9OS721OSV II™  2 piece system, Burr-Hole system with antechamber, F8 striped ventricular catheter w/non radiopaque length markers


Integra Low Flow Valves

Catalogue NumberDescription
909500Standard, Valve Unit with Antechamber
909501Standard, Valve Unit without Antechamber
909506Standard, Shunt System, One-Piece, 9 cm Ventricular Catheter, with Antechamber
909510Lumbar, Shunt System, Two-Piece, without Antechamber
909512Standard, Shunt System, Two-Piece, 15 cm Ventricular Catheter, with Antechamber
909513Standard, Shunt System, Two-Piece, 15 cm Ventricular Catheter, without Antechamber
909514Standard, Shunt System, Two-Piece, 15 cm Ventricular Catheter, Tunneler, with Antechamber
909520Standard, Burr Hole Shunt System, Two-Piece, 15 cm Ventricular Catheter, without Antechamber
909521Standard, Burr Hole Shunt System, Two-Piece, 15 cm Ventricular Catheter, with Antechamber
909507SStandard, Shunt System, Two-Piece, with Antechamber
909508SStandard, Shunt System, Two-Piece, without Antechamber
9OS512Standard, 2 piece system with antechamber, F8 striped ventricular actheter w/non radiopaque length markers
9OS521Standard, 2 piece burr hole system with antechamber, F8 striped ventricular catheter w/non radiopaque length markers
909500PMini, Valve unit with low profile antechamber
909512PMini, Two piece system: valve  with low profile antechamber Separate 15cm ventricular catheter
9OS512PMini, 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

For more information, please contact your Integra representative.
For complete product information, please consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions, and instructions for use.