MIETHKE M.blue®

Adjustable gravitational valve for the treatment of hydrocephalus

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MIETHKE M.blue®

M.blue® is the essence of over 28 years of experience with valve technology for the treatment of hydrocephalus and is based on feedback from numerous doctors and patients worldwide. 
M.blue® focuses on the patient's active time, which is mostly spent sitting or upright and takes up about 2/3 of a day. This is where the greatest risk of positional overdrainage exists. 
With its adjustable gravitational unit and a wide adjustment range of 0-40 cmH2O, the valve can be adapted to the individual requirements in life with hydrocephalus: mobility, growth and changes in the course of the disease [1], [2], [3], [4] 
The M.blue® is a position-dependent hydrocephalus valve. It consists of an adjustable gravitational unit and a fixed differential pressure unit. 
Particularly challenging and difficult forms of hydrocephalus require a much higher degree of flexibility in treatment. This is what the M.blue® plus stands for: a combination of adjustable gravitational unit and adjustable differential pressure unit (proGAV® 2.0). 

Advantages

  • ONE valve for the special requirements of a life with hydrocephalus: mobility, growth, changes in the course of disease [1], [2], [3], [4] 
  • 2 in 1 technology: adjustable gravitational unit combined with fixed differential pressure unit in one valve 
  • Unique uncompromising pressure adaption to fulfill individual patient needs [11], [12] 
  • Smallest adjustable gravitational valve worldwide 
  • Efficient protection against over drainage through individually and continuously adjustable opening pressure from 0-40 cmH2O [5], [6] [7], [8] 
  • MRI-compatible up to 3 Tesla - no X-ray control after MRI necessary, no additional radiation exposure for the patient [9], [10] 
  • Safe from unintentional adjustment by everyday magnets such as smartphones, toys, induction cookers or safety barriers at the airport [9], [10] 
  • Innovative M.blue plus® Instruments for M.blue® and proGAV® 2.0 
  • Intuitive, secure and comfortable adjustment 
  • Precision engineering 
  • Robust and durable: made of titanium 

Contact

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Features

  • Length single valve: 25 mm
  • Diameter: 16,6 mm
  • Height: 4,2 mm
  • Material: Titanium

Note

Because the opening pressure of the valve depends on the position of the patient, M.blue® must be implanted parallel to the body axis.

Indication

Treatment of Hydrocephalus

[1] 2010, Mar, Sprung C., Schlosser H. G., Lemcke J., Meier U., Messing-Junger M., Trost H. A., Weber F., Schul C., Rohde V., Ludwig H. C., Hopfner J., Sepehrnia A., Mirzayan M. J. and Krauss J. K.: "The adjustable proGAV shunt: a prospective safety and reliability multicenter study", Neurosurgery 66(3): 465-474 

[2] 2015, Oct, Kehler U., Kiefer M., Eymann R., Wagner W., Tschan C. A., Langer N., Rohde V., Ludwig H. C., Gliemroth J., Meier U., Lemcke J., Thomale U. W., Fritsch M., Krauss J. K., Mirzayan M. J., Schuhmann M. and Huthmann A.: "PROSAIKA: a prospective multicenter registry with the first programmable gravitational device for hydrocephalus shunting", Clin Neurol Neurosurg 137: 132-136 

[3] 2018, Jan, Antes S., Stadie A., Muller S., Linsler S., Breuskin D. and Oertel J.: "Intracranial Pressure-Guided Shunt Valve Adjustments with the Miethke Sensor Reservoir", World Neurosurg 109: e642-e650 

[4] NPH-Leitlinien der DGN 2018 

[5] 2013, Lemcke J., Meier U., Muller C., Fritsch M. J., Kehler U., Langer N., Kiefer M., Eymann R., Schuhmann M. U., Speil A., Weber F., Remenez V., Rohde V., Ludwig H. C. and Stengel D.: "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 84(8): 850-857 

[6] 2014, Tschan C. A., Antes S., Huthmann A., Vulcu S., Oertel J. and Wagner W.: "Overcoming CSF overdrainage with the adjustable gravitational valve proSA", Acta Neurochir (Wien) 156(4): 767-776, 

[7] 2017, May, Alavi S.,Schulz M., Schaumann A., Schwarz K. and Thomale U. W.: "Valve exchange towards an adjustable differential pressure valve with gravitational unit, clinical outcome of a single-center study", Childs Nerv Syst 33(5): 759-765 

[8] 2016, May, Gebert A. F., Schulz M., Schwarz K. and Thomale U. W.: "Longterm survival rates of gravityassisted, adjustable differential pressure valves in infants with hydrocephalus", J Neurosurg Pediatr 17(5): 544-551 

[9] 2016, May 15, Miyake H.: "Shunt Devices for the Treatment of Adult Hydrocephalus: Recent Progress and Characteristics", Neurol Med Chir (Tokyo) 

[10] 2017, Pierson M. J., Wehrmann D., Albers J. A., El Tecle N. E., Costa D. and Elbabaa S. K.: "Programmable shunt valve interactions with osseointegrated hearing devices", J Neurosurg Pediatr 19(4): 384-3 

[11] 2019, Aschoff A: "In-Depth View: Functional Characteristics of CSF Shunt Devices (Pros and Cons)", Textbook of Pediatric Neurosurgery, Editor: C. Di Rocco90 56(5): 274-28210 

[12] 2020, Gutowski P., Golz L., Rot S., Lemcke J. and Thomale U. W.:"Gravitational shunt valves in hydrocephalus to challenge the sequelae of over-drainage", Expert Rev Med Devices 17(11): 1155-1168