M.Blue® Valve 

Aesculap, Inc.
Healthcare Professionals
Neurosurgery
Hydrocephalus
M.blue Valve

Adjustable Gravitational Valve for the Treatment of Hydrocephalus

Take the Headaches Out of Treating Hydrocephalus with Gravitational Technology That Protects from Overdrainage 

The M.blue® Valve is a position-dependent hydrocephalus valve that combines a fixed differential pressure unit with an adjustable gravitational unit. The result is an all-in-one system that is designed to adjust automatically depending on the patient’s position, thus countering the risk of possible overdrainage complications.


 

Illustration of MIETHKE m.Blue Valve showing features

M.blue Valve Features:

  • One valve for the special requirements of a life with hydrocephalus
  • Unique pressure adaption to optimize individual patient needs 
  • Efficient protection against overdrainage through individually and continuously adjustable opening pressure from 0-40 cmH2O1 
  • MRI-compatible up to 3 Tesla – No need for X-ray verifications post-MRI, minimizing patient radiation exposure2
  • Safe from unintentional adjustment from everyday magnet3
  • Designed to be intuitive, secure and comfortable to adjust
  • Precision engineering
  • Robust and durable: made of titanium
     


 

The Only Adjustable Gravitational Valve

2-in-1 Technology: An adjustable gravitational unit combined with a fixed differential pressure unit that adjusts to a patient’s mobility, growth and changes in condition.

  • Automatic Adjustment: Gravitational technology adjusts based on the patient’s position to prevent overdrainage with adjustable opening pressure from 0-40 cmh201
  • Pressure adaption to optimize individual patient needs:
      - Differential pressure unit available in 0, 5, 10 and 15 cmH2O
      - Activated in the upright position for finer pressure settings
      - Suitable for low-pressure hydrocephalus with a zero-pressure     setting 
MIETHKE m.Blue Valve for hydrocephalus treatment


 

The image features two pie charts comparing overdrainage rates with different types of valves. The left pie chart shows a 43% overdrainage rate with conventional valves, depicted by a dark blue segment covering almost half of the circle against a light grey background. The right pie chart shows a 7% overdrainage rate with gravitational valves, indicated by a much smaller dark blue segment against the same light grey background. Below each chart, the corresponding type of valve and overdrainage rate are labeled for clarity.

Better Protection. Better Outcomes.

Clinical studies have shown that MIETHKE Gravitational Devices reduce the risk of revisions and overdrainage complications.1,4-6

  • Valve survival rates up to 90% at 12 months4
  • Implanting a gravitational valve avoids one additional overdrainage complication in about every third patient1
  • Enhanced patient outcomes, including minimizing overdrainage complications and improved cognitive function, with gravitational valves compared to conventional ones7


 

Simplified Valve Adjustment and Verification 

M.blue plus® Instruments allow users to measure, verify and adjust the pressure level on the M.blue Valve’s adjustable gravitational unit (0-40 cmH2O) as well as the pressure level on the adjustable differential pressure unit (proGAV® 2.0 Valve) of the M.blue plus Valve. The instruments help to offer simple steps for the physician and make the adjustment process comfortable for patients.

 

 

 

 

Locate

Locate the valve by palpating the area with your finger through the open M.blue plus Compass.

 

 

Verify

Close the M.blue plus Compass and use the floater to lock location and read the current valve opening pressure setting.

 

 

Adjust

With the help of the inserted adjustment ring, the valve opening pressure can easily be set to the desired level. After setting the valve opening pressure, it is advisable to double-check the pressure level settings.

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Resources

References:
1Lemcke J, Meier U, Muller C, et al. Safety and efficacy of gravitational shunt valves in patients with idiopathic normal pressure hydrocephalus: a pragmatic, randomised, open label, multicentre trial SVASONA. J Neurol Neurosurg Psychiatry 2013;848:850-7
2Aesculap, Inc. Data on File
3Spader HS, Ratanaprasatporn L, Morrison JF, Grossberg JA, Cosgrove GR. Programmable shunts and headphones: Are they safe together? Journal of Neurosurgery: Pediatrics. 2015;16(4):402-405. doi:https://doi.org/10.3171/2015.1.peds14400
4Golz L, Lemcke J, Meier U. Indications for valve-pressure adjustments of gravitational assisted valves in patients with idiopathic normal pressure hydrocephalus. Surg Neurol Int 2013;4:140.
5Sprung C, Schlosser HG, Lemcke J, et al. The adjustable proGAV shunt: a prospective safety and reliability multicenter study. Neurosurgery 2010;663:465-74.
6Thomale UW, Gebert AF, Haberl H, et al. Shunt survival rates by using the adjustable differential pressure valve combined with a gravitational unit proGAV in pediatric neurosurgery. Childs Nerv Syst 2013;293:425-31.
7Suchorska B, Kunz M, Schniepp R, et al. Optimized surgical treatment for normal pressure hydrocephalus: comparison between gravitational and differential pressure valves. Acta Neurochirurgica. 2015;157(4):703-709. doi:https://doi.org/10.1007/s00701-015-2345-4

For MRI safety information, please see Instructions for Use.

See Instructions for Use for complete Indications, including Contraindications, Warnings and Precautions