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Integra® Flow Regulating Valves


Integra® Flow Regulating Valves are the only hydrocephalic shunt valves that use variable resistance to flow to ensure that the flow of cerebrospinal fluid (CSF) is maintained at a physiologic rate of production, thus minimizing the potential risks associated with both postural and vasogenic overdrainage.

Integra's unique flow regulating technology provides a close balance between CSF production and drainage rate. Integra Flow Regulating Valves are able to transition from a valve with a low opening pressure to one with a higher pressure by reducing the size of the valve opening as pressure increases.

By adjusting the CSF flow rate in response to differential pressure, the valve ensures that CSF flow does not reach an excessive rate. Thus the size of the ventricles is gradually reduced and limits the risks associated with overdrainage.

Flow Regulating Valves:

  • Address the patient's changing pressure needs without manual adjustments
  • Are considered Magnetic Resonance (MR) Conditional in accordance with ASTM F2503


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
Patients with thin skin

Flow Rate: 8-17 ml/hr
Size: 36 mm (L) x 12.5 mm (W) x 5.8 mm (H)




Ventriculo - Peritoneal Shunts:

Indications
Integra Flow Regulating Valves are implantable systems 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) 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.

Integra Flow Regulating Valves 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.

See Instructions For Use for complete product information

Integra Flow Regulating Valves 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.


Integra OSV II and Integra Flow Regulating Valve Low Flow, Lumbar
Integra's unique flow regulating technology is now available for implantation in the lumbar subarachnoid space. The complete procedure ready kit requires one simple connection, there by reducing assembly time in the OR suite.

OSV II Lumbar Valve System
Flow Rate: 18-30 ml/hr

Integra Flow Regulating Valve Low Flow, Lumbar
Flow Rate: 8 -17 ml/hr

Size: 40.5 mm (L) x 12.5 mm (W) x 7.9 mm (H)




Lumbo - Peritoneal shunts:

Indications
Integra Lumbar Valve Systems are implantable systems used in the treatment of patients with communicating hydrocephalus to shunt CSF from the lumbar subarachnoid region to the peritoneal cavity.

Contraindications
The Integra Lumbar Valve Systems should not be used in patients with non-communicating hydrocephalus.

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.

Integra Lumbar Valve Systems 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 Integra Lumbar Valve Systems would underdrain under these conditions.

See Instructions For Use for complete product information

Warning
The Integra OSV II lumbar valve should be used in patients who need a drainage rate close to the CSF secretion rate (18-30 ml/hr). For patients who need a lower drainage rate (8-17 ml/hr), the Integra Integra Flow Regulating Valve Low Flow, Lumbar should be used.

NOTE: 10 cm of the Lumbar catheter will add, at 10 ml/hr, an extra resistance of 2.4 mmH20 (hydrodynamic resistance of the Lumbar catheter: 0.024 mm H20 per ml/hr and per cm).




For complete product information, please see the Instructions for Use accompanying each product.
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