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M.blue®
44Pages

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Catalog excerpts

M.blue® - 1

M.blue® THE BALANCED WAY OF LIFE. INSPIRED BY YOU.

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M.blue® - 2

TREATMENT OF HYDROCEPHALUS NEED FOR ACTION WHY DOES IT NEED BETTER SOLUTIONS FOR THE TREATMENT OF HYDROCEPHALUS? Since the 1960s, the main surgical strategy in managing hydrocephalus is the placement of shunts. However, conventional shunts have very high failure rates, and nearly every fourth patient is affected by complications (1, 2) with no difference between different conventional valves and programmable valves (4, 5). Overdrainage-related complications can necessitate a variety of different revisions, which are burdensome for patients and are accompanied by unavoidable perioperative...

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M.blue® - 4

TREATMENT OF HYDROCEPHALUS NEED FOR ACTION MECHANICAL FAILURE Mechanical failure is the most common cause of multiple shunt revisions (6), with catheter or valve obstruction being the predominant reason (3). However, failure of individual shunt components may also occur, e.g., at stress points or due to poor design (7). Catheter breakage Catheter separation Catheter fracture Damaged housing Valve migration

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M.blue® - 5

ACCIDENTAL REPROGRAMMING As the optimal pressure setting of adjustable valves is of great importance for the patient, the accidental reprogramming of adjustable valves by external magnetic fields, e.g., from smartphones, is a cause of concern and leads to great uncertainty among patients and doctors (8-12). Mobile devices

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M.blue® - 6

TREATMENT OF HYDROCEPHALUS NEED FOR ACTION WHAT COULD BE BETTER? Active patients are exposed to gravity – for up to 16 hours, every day. Posture-dependent gravitational effects increase the potential for overdrainage. Overcoming these gravitational effects can help to improve patient outcomes.

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M.blue® - 7

NO TWO PATIENTS ARE ALIKE! Every patient with hydrocephalus is unique and requires customized setting of the valve opening pressure. ARE PATIENTS GETTING OPTIMAL INDIVIDUAL TREATMENT? Determining the patient-individual setting of the valve opening pressure can be complex. Non-ideal pressure settings can lead to follow-up examinations and revisions, which are burdensome for patients and put an additional strain on physicians and surgeons with limited time and high workload (13, 14). ARE ADJUSTABLE DIFFERENTIAL PRESSURE VALVES THE BEST AVAILABLE THERAPIE? The pressure setting of conventional...

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M.blue® - 8

GRAVITATIONAL VALVES BY MIETHKE DEVELOPED TO ENSURE SAFETY BE CONFIDENT! Gravitational shunts provide neurosurgeons with a possibility to address the posture-dependent effects of gravity, with positive clinical outcomes for the patient and a significant reduction of overdrainage events (15). GRAVITATIONAL VALVES (GV) IMPROVE PATIENT OUTCOMES COMPARED TO DIFFERENTIAL PRESSURE VALVES (DP) (16). Symptom improvement >2 points on Kiefer-Scale. GV DP Daily improvement rated good / very good on Black-Scale. GV DP

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M.blue® - 9

REDUCE COMPLICATIONS! REDUCE REVISIONS! Clinical studies have shown that MIETHKE gravita tional devices reduce the risk of revisions (17-21) and over rainage complications (18). d Valve survival rates up to 90 % at 12 months (19). 43 % Overdrainage rate with differential pressure valves 7 % Overdrainage rate with gravitational valves Implanting a gravitational valve avoids one additional overdrainage complication in about every third patient (18

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M.blue® - 10

GRAVITATIONAL VALVES BY MIETHKE DEVELOPED TO ENSURE SAFETY AVOID MECHANICAL FAILURE! All MIETHKE valves are manufactured with high precision from titanium. The extremely small valves have aligned flow paths, rigid housing unsusceptible to subcutaneous pressure and high MRI- and biocompatibility. DON’T LET MAGNETIC FIELDS BOTHER YOU! The “Active-Lock mechanism” protects programmable MIETHKE valves against reprogramming by magnetic fields of up to 3 Tesla (22). MIETHKE GRAVITATIONAL VALVES Ti Made from Titanium for high MRI- and biocompatibility Extremely small valve Protected against...

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M.blue® - 11

BENEFIT FROM PRIMARY IMPLANTATION (23)! 22 % higher survival of gravitational valves after primary vs secondary implantation GET IT RIGHT THE FIRST TIME! Early treatment with the optimal therapy is important for patients with hydrocephalus (23, 24) and can also help to avoid shunt replacements and associated perioperative risks. OPTIMIZE – DON’T COMPROMISE! Gravitational shunts allow for the prevention of overdrainage in the standing position without compromising the pressure setting for the supine position. The optimal opening pressure for each patient can be set both for the upright and...

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M.blue® - 12

OUR LATEST GENERATION OF VALVE TECHNOLOGY requirements life with · ONE valve for the specialgrowth, changesofinathe course of disease hydrocephalus: mobility, technology: adjustable unit · 2 in 1fixed differential pressuregravitational valvecombined with unit in one · Unique uncompromising pressure adaption to fulfill individual patient needs · Smallest adjustable gravitational valve worldwide · Efficient protection against overdrainage through individually O and continuously adjustable opening pressure from 0-40 cmH Tesla – no X-ray verification after · MRI-compatible up to 3 radiation...

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M.blue® - 13

M.blue & M.blue plus ® M.blue is the essence of 26 years of experience with ® hydrocephalus and valve technology and the feedback of numerous physicians and patients worldwide. M.blue is a valve for all forms of hydrocephalus with a ® particularly high flexibility in therapy.

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M.blue® - 14

FUNCTIONALITY OF VALVE AND POSITION OF THE BODY ADJUSTABLE GRAVITATIONAL UNIT Sapphire ball Tantalum weight Rotor DIFFERENTIAL PRESSURE UNIT Sapphire ball Microspiral spring The functionality of M.blue is illustrated interactively in the MIETHKE app. ®

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M.blue® - 15

EXAMPLE OF THE ADJUSTABLE GRADUATED PRESSURE RANGE OF A M.blue WITH A DIFFERENTIAL PRESSURE UNIT OF 5 CMH2O ® Gravitational unit adjustment range Valve opening pressure (cmH2O) Gravitational unit and differential pressure unit work together when the patient is standing Only the differential pressure unit is active when the patient is supine 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 adjusts the opening pressure automatically depending on...

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