Model note · CSF Shunt
Christoph Miethke proGAV 2.0 adjustable differential pressure valve
The proGAV 2.0 is a titanium hydrocephalus shunt valve whose opening pressure can be changed through the skin with a handheld magnetic tool. A bow spring presses a sapphire ball into a cone, and a magnetic rotor alters the spring preload anywhere from 0 to 20 cmH2O. It is normally combined with a gravitational unit that adds resistance when the patient stands up, to limit overdrainage. In the US it is sold by Aesculap and cleared under 510(k) K141687.
The model
Maker, model and type.
- Maker
- Christoph Miethke GmbH & Co. KG, distributed by B. Braun / Aesculap
- Model
- proGAV 2.0 adjustable differential pressure valve (usually paired with SHUNTASSISTANT 2.0 gravitational unit)
- Device type
- CSF Shunt
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Opening pressure range (adjustable unit) | 0 to 20 cmH2O, infinitely variable | Source |
| Factory preset | 5 cmH2O, to be checked before implantation | Source |
| Gravitational unit options (SA 2.0) | 10, 15, 20, 25, 30 or 35 cmH2O, identified by coding on X-ray | Source |
| Materials | Titanium alloy Ti6Al4V housing, neodymium iron boron magnets, sapphire ball | Source |
| Size | Height 4.5 mm, diameter 17 mm, four rotor magnets | Source |
| Pressure resistance | Positive and negative pressures up to 200 cmH2O during and after implantation | Source |
| Supplied catheters | Inner diameter 1.2 mm, outer diameter 2.5 mm | Source |
| MRI | MR Conditional; manufacturer states MRI up to 3 T does not impair valve function | Source |
| Maximum single adjustment | No more than 8 cmH2O change per adjustment step | Source |
| FDA clearance | K141687, product code JXG, Class II, cleared 2 April 2015 | Source |
Recalls
Recalls.
This note lists no recalls. Check the FDA recall database for the latest record.
Safety
Safety warnings from the record.
- A change of more than 8 cmH2O in one step can turn the rotor the short way round to the wrong setting; large changes must be done in stages. Source
- If a magnetic field and pressure on the valve occur together, for example in MRI, an unintended adjustment cannot be ruled out, and MRI artefacts are larger than the valve. Source
- The adjustment tools contain magnets: keep them away from pacemakers and out of the MRI scanner room. Source
- Frequent pumping of a reservoir can overdrain and push pressure outside the normal range. Source
- An implanted valve must never be re-implanted in another patient. Source
Sources
Where this note comes from.
- FDA 510(k) K141687 summary, Aesculap Miethke proGAV 2.0 Adjustable Shunt System
- Miethke proGAV 2.0 instructions for use (EU, multilingual, V04)
- Miethke proGAV 2.0 product page
- openFDA MAUDE problem counts, brand proGAV 2.0
Not covered: Implanted valves have no error codes, so that section is empty. The EU instructions for use were used for most details; the US Aesculap labelling was not opened and may differ (the US clearance requires X-ray confirmation of settings). No FDA recall record was found for proGAV 2.0 through openFDA. MRI detail beyond the 3 T statement sits in a separate Miethke MRI safety sheet that was not read.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
CSF Shunt