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MIETHKE M.blue®

Adjustable gravitational valve for the treatment of hydrocephalus

M.blue® – the next generation

Functionality of valve and position of the body

The M.blue® is a hydrocephalus valve operating in a position-dependent manner. It consists of an adjustable gravitational unit and a fixed differential pressure unit.

The combination of these two units ensures automatic adjustment of the opening pressure depending on the patient's body position and thus counteracts the risk of possible overdrainage complications, especially in the upright and active body position. [5], [6], [7], [8] Particularly challenging and difficult forms of hydrocephalus require a much greater flexibility in treatment. This is what the M.blue plus® stands for: a combination of an adjustable gravitational unit and an adjustable differential pressure unit (proGAV® 2.0). Both M.blue® variants are made of robust and biocompatible titanium and are the result of precise precision engineering.

XABO® antibiotic impregnated catheters perfectly fit to our innovative MIETHKE M.blue® valve. It offers long-lasting antimicrobial effects for at least 38 days after implantation, easy handling as it withstands temperatures up to 30°C without losing its effectiveness [21] and convenient storage for up to 36 months.

Related product

Valve adjustment

User-friendly adjustment and verification

M.blue plus® instruments allow users to measure, verify, and adjust the pressure level on M.blue®’s adjustable gravitational unit (0-40 cmH2O) as well as the pressure level on the adjustable differential pressure unit (proGAV® 2.0) of M.blue plus®. The instruments offer simple steps for the physician and make the adjustment process comfortable for patients. [22]

Related documents

Standard pressure levels for M.blue® and M.blue plus®

Sheet

pdf, 111.0 KB

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Challenges for hydrocephalus shunt development

Info graph

pdf, 45.4 KB

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MIETHKE Gravitational valves – designed to give you confidence

Info graph

pdf, 36.8 KB

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M.blue® – shunt system for the treatment of hydrocephalus

Patient manual

link

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M.blue® – the balanced way of life. Inspired by you.

Brochure

link

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XABO® Antibiotic impregnated catheters – Xtra protection against infection

Brochure

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[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

[13] Okamura Y, Maruyama K, Fukuda S, et al. Detailed standardized protocol to prevent cerebrospinal fluid shunt infection. J Neurosurg 2019:1-5.

[14] Fernández-Méndez R, Richards HK, Seeley HM, et al. Current epidemiology of cerebrospinal fluid shunt surgery in the UK and Ireland (2004-2013). J Neurol Neurosurg Psychiatry 2019;90(7):747-54.

[15] Blount JP, Campbell JA, Haines SJ. Complications in Ventricular Cerebrospinal Fluid Shunting. Neurosurgery Clinics of North America 1993;4(4):633-56.

[16] Darouiche RO. Treatment of infections associated with surgical implants. N Engl J Med 2004;350(14):1422-29.

[17] Walters BC, Hoffman HJ, Hendrick EB, et al. Cerebrospinal fluid shunt infection. Influences on initial management and subsequent outcome. J Neurosurg 1984;60(5):1014-21.

[18] Sciubba DM, Stuart RM, McGirt MJ, et al. Effect of antibiotic-impregnated shunt catheters.

[19] Mallucci CL, Jenkinson MD, Conroy EJ, et al. Antibiotic or silver versus standard ventriculoperitoneal shunts (BASICS): a multicentre, single-blinded, randomised trial and economic evaluation. The Lancet 2019;394(10208):1530-39.

[20] MIETHKE report. Data on file.

[21] MIETHKE report. Data on file.

[22] 2013, Nov, Gebert A. F., Schulz M., Haberl H. and Thomale U. W.: "Adjustments in gravitational valves for the treatment of childhood hydrocephalus-a retrospective survey", Childs Nerv Syst 29(11): 2019-2025

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