Prosa
Active people spend about 2/3 of the day walking,standing or sitting upright.Consequently, hydrocephalus patients carrying a shunt often risk overdrainage. The introduction of the gravitational technology for hydrocephalus treatment brought new options to avoid the symptoms and long-term complications caused by overdrainage.
The Miethke valves proGAV, GAV, and paediGAV based on this technology offer effective solutions for pediatric and adult hydrocephalus.
The new proSA is the result of continuous evolution of the proven and accepted gravitational technology. The proSA allows individual adjustment, which can be necessitated by body growth or increased peritoneal pressure.
The proSA valve offers extended options and possibilities for all fields of hydrocephalus treatment, beyond the limitations of conventional adjustable shunt systems. The pressure setting range of 0 to 40 cmH2O allows individual adjustment for each patient.
Like the proGAV,the proSA is featured with an ‘’Active Lock’’ mechanism. This mechanism protects the valve against inadvertent adjustment by external magnetic fields, making it MR-compatible up to 3 tesla.
The patented adjustment and verification instrument allow easy,fast and uncomplicated treatment at any location,without having to expose the patient to X-ray.
The proSA valve can be combined with any differential pressure valve,although we recommed using the new Miethke miniNAV.
‘’The analysis of our material demonstrates that gravitational shunt systems for treatment of adult chronic hydrocephalus minimize the risk of overdrainage.’’
• Source:’’Five Years Experience with Gravitational Shunts in Chronic Hydrocephalus of Adults’’ M.Kiefer,R.Eymann and U.Meier.
Acta Neurochir(2002) 144:755-767
‘’Adding a gravitational unit to a preexisting or newly inserted shunt system is able to reduce the occurrence or severity of an overdrainage syndrome in shunted hydrocephalic children.’’
• Source: ‘’ Treatment of Overdrainage Syndrome in Shunted Pediatric Patients with Additional Gravitational Unit’’ A.M. Messing-Junger M.D.,Luisa Wilms,Poster Presented at AANS/CNS Section on Pediatric Neurological Surgery
December 8-11,2004 San Francisco,CA
We recommed:
* The less mobile the patient,the lower the opening pressure to be set.
Our recommended pressure setting for adult patients:
Differential pressure unit-5cmH2O
Gravitational unit-25cmH2O
Our reommended pressure setting for pediatric patients and adults over 60 years of age:
Differential pressure unit-5cmH2O
Gravitational unit-20cmH2O
* Individual characteristics of the patient e.g. the Body Mass Index,adiposity,pregnancy,growth of pediatric patients, etc. can be easily adapted for by adjusting the gravitational unit in the course of the therapy.
Supine Function
The proSA is an adjustable gravitational valve whose opening pressure automatically adapts to the patient’s body position.
* In the supine position,the opening pressure of the proSA is 0 cmH2O
* In this mode,the shunt opening pressure is completely defined by the differential pressure unit.
The graph only represents the opening pressure of the proSA.For the opening pressure of the shunt system as a whole,the opening pressure of the differential pressure unit has to be added in.
Upright Function
* When the patient is in an upright position, the gravitational unit and the differential pressure unit work together, i.e. the opening pressure of the shunt system as a whole is the sum of the differential pressure level and the pressure level set at the adjustable gravitational unit ( proSA )
Localization
The proSA is located by palpation
Verification
Position the verification instrument according to instruction for use on the valve. Press the trigger button to see the actual opening pressure setting displayed in the window.
Adjutment
Select the appropriate opening pressure on the adjustment instrument. Position the instrument according to instruction for use on the valve. Unlock the mechanical coupling ‘’Active-Lock’’ by applying mild pressure on the trigger button and set the intended opening pressure of the adjustable valve. Any adjustment can easily be confirmed using the verification instrument.
Valve
Available as adjustable valve only or in combination with differential pressure unit.
Standard pressure levels. These guide values are not binding. Other specifications may be preferable depending on the individual patient and anamnesis. 1cmH2O=0.74 mmHg
Valve with integrated distal catheter
Available as adjustable valve only or in combination with differential pressure unit
Shunt system with two connections
* Adjustable gravitational unit with integrated distal catheter
* Sprung reservoir with integrated distal catheter; optional combination with differential pressure unit.
* Ventricular catheter with introducing stylet.
Shunt system with two connections
* Adjustable gravitational unit with integrated distal catheter
* Control Reservoir with integrated distal catheter; optional combination with differential pressure unit.
* Ventricular catheter with introducing stylet and deflector.
Shunt system with two connection ports
* Adjustable gravitational unit with integrated distal catheter
* Pediatric flushing reservoir with integrated distal catheter; optional combination with differential pressure unit
* Ventricular catheter with introducing stylet and pediatric deflector
Shunt system with two connection ports
* Adjustable gravitational unit with integrated distal catheter
* Pediatric burrhole reservoir with integrated distal catheter; optional combination with differential pressure unit.
* Ventricular catheter with introducing stylet
Instrument for valve adjustment
* ProSA adjustment instrument for setting the required opening pressure.
* Prosa verification instrument for reading the actual opening pressure setting.
The Miethke valves proGAV, GAV, and paediGAV based on this technology offer effective solutions for pediatric and adult hydrocephalus.
The new proSA is the result of continuous evolution of the proven and accepted gravitational technology. The proSA allows individual adjustment, which can be necessitated by body growth or increased peritoneal pressure.
The proSA valve offers extended options and possibilities for all fields of hydrocephalus treatment, beyond the limitations of conventional adjustable shunt systems. The pressure setting range of 0 to 40 cmH2O allows individual adjustment for each patient.
Like the proGAV,the proSA is featured with an ‘’Active Lock’’ mechanism. This mechanism protects the valve against inadvertent adjustment by external magnetic fields, making it MR-compatible up to 3 tesla.
The patented adjustment and verification instrument allow easy,fast and uncomplicated treatment at any location,without having to expose the patient to X-ray.
The proSA valve can be combined with any differential pressure valve,although we recommed using the new Miethke miniNAV.
‘’The analysis of our material demonstrates that gravitational shunt systems for treatment of adult chronic hydrocephalus minimize the risk of overdrainage.’’
• Source:’’Five Years Experience with Gravitational Shunts in Chronic Hydrocephalus of Adults’’ M.Kiefer,R.Eymann and U.Meier.
Acta Neurochir(2002) 144:755-767
‘’Adding a gravitational unit to a preexisting or newly inserted shunt system is able to reduce the occurrence or severity of an overdrainage syndrome in shunted hydrocephalic children.’’
• Source: ‘’ Treatment of Overdrainage Syndrome in Shunted Pediatric Patients with Additional Gravitational Unit’’ A.M. Messing-Junger M.D.,Luisa Wilms,Poster Presented at AANS/CNS Section on Pediatric Neurological Surgery
December 8-11,2004 San Francisco,CA
- Wide range of pressure levels for adjustment between 0 and 40cmH2O
- Effective protection against overdrainage.
- "Active-Lock" mechanism prevents inadvertent pressure level readjustments caused by external magnetic fields.
- 3 tesla MR compatible and safe.
- X-ray-free verification of the pressure level setting.
- Patented instruments for quick and easy adjustment of the pressure level.
- Titanium shell ensuring reliable operation independent of external and subcutaneous pressures.
We recommed:
- The proSA valve should be implanted in combination with a differential pressure unit of 5 cmH2O
- The opening pressure of the proSA valve should be set according to the body height of the patient: Higher pressure settings for taler patients,lower settings for shorter or more adipose patients. The pressure setting should be selected by the height difference between the third ventricle and the diaphragm.
* The less mobile the patient,the lower the opening pressure to be set.
Our recommended pressure setting for adult patients:
Differential pressure unit-5cmH2O
Gravitational unit-25cmH2O
Our reommended pressure setting for pediatric patients and adults over 60 years of age:
Differential pressure unit-5cmH2O
Gravitational unit-20cmH2O
* Individual characteristics of the patient e.g. the Body Mass Index,adiposity,pregnancy,growth of pediatric patients, etc. can be easily adapted for by adjusting the gravitational unit in the course of the therapy.
Supine Function
The proSA is an adjustable gravitational valve whose opening pressure automatically adapts to the patient’s body position.
* In the supine position,the opening pressure of the proSA is 0 cmH2O
* In this mode,the shunt opening pressure is completely defined by the differential pressure unit.
The graph only represents the opening pressure of the proSA.For the opening pressure of the shunt system as a whole,the opening pressure of the differential pressure unit has to be added in.
Upright Function
* When the patient is in an upright position, the gravitational unit and the differential pressure unit work together, i.e. the opening pressure of the shunt system as a whole is the sum of the differential pressure level and the pressure level set at the adjustable gravitational unit ( proSA )
Localization
The proSA is located by palpation
Verification
Position the verification instrument according to instruction for use on the valve. Press the trigger button to see the actual opening pressure setting displayed in the window.
Adjutment
Select the appropriate opening pressure on the adjustment instrument. Position the instrument according to instruction for use on the valve. Unlock the mechanical coupling ‘’Active-Lock’’ by applying mild pressure on the trigger button and set the intended opening pressure of the adjustable valve. Any adjustment can easily be confirmed using the verification instrument.
Valve
Available as adjustable valve only or in combination with differential pressure unit.
| Art no: | Differential pressure unit (not adjustable) (cmH2O) Gravitational unit (adjustable) (cmH2O) |
| FV701T | - 0 to 40 |
| FV702T | 0 0 to 40 |
| FV703T | 5 0 to 40 |
| FV704T | 10 0 to 40 |
| FV705T | 15 0 to 40 |
Standard pressure levels. These guide values are not binding. Other specifications may be preferable depending on the individual patient and anamnesis. 1cmH2O=0.74 mmHg
Valve with integrated distal catheter
Available as adjustable valve only or in combination with differential pressure unit
| Art no: | Differential pressure unit (not adjustable) (cmH2O) Gravitational unit (adjustable) (cmH2O) |
| FV706T | - 0 to 40 |
| FV707T | 0 0 to 40 |
| FV708T | 5 0 to 40 |
| FV709T | 10 0 to 40 |
| FV710T | 15 0 to 40 |
Shunt system with two connections
* Adjustable gravitational unit with integrated distal catheter
* Sprung reservoir with integrated distal catheter; optional combination with differential pressure unit.
* Ventricular catheter with introducing stylet.
| Art no: | Differential pressure unit (not adjustable) (cmH2O) Gravitational unit (adjustable) (cmH2O) |
| FV711T | - 0 to 40 |
| FV712T | 0 0 to 40 |
| FV713T | 5 0 to 40 |
| FV714T | 10 0 to 40 |
| FV715T | 15 0 to 40 |
Shunt system with two connections
* Adjustable gravitational unit with integrated distal catheter
* Control Reservoir with integrated distal catheter; optional combination with differential pressure unit.
* Ventricular catheter with introducing stylet and deflector.
| Art no: | Differential pressure unit (not adjustable) (cmH2O) Gravitational unit (adjustable) (cmH2O) |
| FV716T | - 0 to 40 |
| FV717T | 0 0 to 40 |
| FV718T | 5 0 to 40 |
| FV719T | 10 0 to 40 |
| FV720T | 15 0 to 40 |
Shunt system with two connection ports
* Adjustable gravitational unit with integrated distal catheter
* Pediatric flushing reservoir with integrated distal catheter; optional combination with differential pressure unit
* Ventricular catheter with introducing stylet and pediatric deflector
| Art no: | Differential pressure unit (not adjustable) (cmH2O) Gravitational unit (adjustable) (cmH20) |
| FV721T | - 0 to 40 |
| FV722T | 0 0 to 40 |
| FV723T | 5 0 to 40 |
| FV724T | 10 0 to 40 |
| FV725T | 15 0 to 40 |
Shunt system with two connection ports
* Adjustable gravitational unit with integrated distal catheter
* Pediatric burrhole reservoir with integrated distal catheter; optional combination with differential pressure unit.
* Ventricular catheter with introducing stylet
| Art no: | Differential pressure unit (not adjustable) (cmH2O) Gravitational unit (adjustable) (cmH2O) |
| FV726T | - 0 to 40 |
| FV727T | 0 0 to 40 |
| FV728T | 5 0 to 40 |
| FV729T | 10 0 to 40 |
| FV730T | 15 0 to 40 |
Instrument for valve adjustment
* ProSA adjustment instrument for setting the required opening pressure.
* Prosa verification instrument for reading the actual opening pressure setting.
| Art no: | Instruments |
| FV790T | proSA adjustment instrument |
| FV791T | proSA verification instrument |
| FV792 | proSA instrument set ( comprising FV790T and FV791T ) |