On May 15th, Aesculap Inc., in partnership with MIETHKE, announced the launch of a new valve for hydrocephalus patients called the M.blue valve. This week, we spoke with Odra Anderson, Aesculap Product Manager; Steve Owens, Aesculap Clinical Manager; and Christoph Miethke, Original Engineer and Founder of the Christoph Miethke Company in Potsdam, Germany; about their new valve and what it means for children and adults living with hydrocephalus.
HOW LONG HAS THIS BEEN IN USE IN EUROPE?
Odra Anderson: First of all, thank you for the opportunity to share with you and our hydrocephalus community this great news. We are excited to finally have the M.blue™ Valve in the U.S. The M.blue Valve received its CE mark and the first valve was implanted in Europe in 2018. Since then, hundreds of hydrocephalus patients have been implanted with this 2-in-1 valve. We call it a 2-in-1 valve because the M.blue Valve is the only programmable gravitational valve in the market with an integrated fixed pressure differential pressure (DP) unit. It provides customization of the opening pressure during the most active time of the day, which is the upright body position but also works to relieve the pressure in the lying down position. The M.blue Valve represents over 26 years of Hydrocephalus valve experience. We launched the M.blue Valve in the U.S. just a few weeks ago and have already seen a lot of interest from the hydrocephalus community. The new M.blue Valve has already been implanted in patients from California and Texas and we are looking forward to hearing about the positive outcomes similar to our other gravitational systems.
HOW DOES IT WORK IN LAYMEN’S TERMS?
Steve Owens: I’ll take this question. First, let me say that the new M.blue Valve is the first programmable gravitational valve with an integrated fixed DP unit. Let’s talk about each part of the valve and how it works. The fixed DP unit integrated in the M.blue Valve is basically your “lying down” valve. This relatively low-pressure resistance will facilitate optimal drainage while you sleep. We believe that when someone is lying down there is really no other external influences on a shunt system, such as gravity. With this being said, we can use a fixed or non-programming valve. The unknown or the inconsistent pressure happens once someone sits or stands. Now we have to take into account and adjust for height and in some cases abdominal back pressure and the adaptability of ventricles to large pressure changes. The M.blue Valve can provide both by using an adjustable, 0-40 cm/H2O, gravity device that only adds resistance upon sitting or standing and a low consistent DP valve.
Odra Anderson: The M.blue Valve, with its 2-in-1 design, addresses the “lying down” and the “sitting/standing up” different pressures that a patient encounters.
ANTI-SIPHON AND ANTI-GRAVITATIONAL VALVES HAVE BEEN AROUND FOR A WHILE. HOW IS THIS SHUNT DIFFERENT?
Steve Owens: The M.blue Valve and our gravitational systems provide an uncompromising pressure adaptation to optimize individual patient needs. The M.blue Valve is the only valve that allows you to adjust the gravity device (activated when you are standing or moving around) independently of the DP unit. Most valves require the clinician to increase or decrease the entire shunt resistance to correct a specific symptom. In many cases, this one-sided approach only trades one symptom for another. I heard a surgeon ask a patient once, “When do you want your headaches, AM or PM?” My interpretation was that the patient had to choose between over or under draining. That is not the case for our valves, we can address both.
DOES THIS VALVE CHANGE UNDER AN MRI OR ANY OTHER MAGNETS?
Odra Anderson: The active-lock mechanism protects our programmable valves against reprogramming by magnetic fields up to 3 Tesla. It is protected from unintentional adjustment by everyday magnets such as smartphones, toys, hearing devices, induction cookers and safety barriers at airports. To put that in perspective, 1 Tesla is equal to 10,000 gauss. Gauss is how you measure magnetic induction and a typical fridge magnet is approximately 100 gauss. We tested the brake safety and effects of exposure to MRI conditions up to 3 Teslas and verified that the MRI exposure had no effect on the valve function and adjustability. The active-lock protects against inadvertent re-adjustment by external magnetic field and it can only be changed by the physician with a special tool to mechanically unlock the brake. The M.blue Valve is MR Conditional up to 3 Tesla.
HOW DID YOU COME UP WITH THE NEW VALVE?
Christoph Miethke: Around the same time we developed the proGAV® 2.0 Valve, it became clear to us that the same improved features can be extended to our programmable gravitational valve. For the patient, the upright position is more variable, in terms of height, conditions/ circumstances and even the BMI factors just like Steve said. The need to have variability and choice to adjust this aspect is key.
Over-drainage is a dangerous complication that happens in the upright position. Our programmable gravitational valve, the proSA® Valve addresses that need. Looking at the improvements that we were applying to the original proGAV Valve, we wanted to do the same to the proSA Valve. This thought led to the improvement project and the decision to integrate a DP unit to the adjustable gravitational valve. By adding the DP unit, this allowed for a 2-in-1 design. To take it a step further, using both programmable valves, the proGAV 2.0 Valve and the M.blue Valve, offer the best of both worlds. These valves are designed to be used for all patients (pediatric and adults). For particularly challenging forms of hydrocephalus that require an even greater flexibility in treatment, this could be a great solution.
In line with all of our actions and innovation is the direct line to collaboration with neurosurgeons and patients. We often sought the feedback of those within the hydrocephalus community. A lot of requirements, wishes and feedback have been incorporated directly into this product. That is why we say that the M.blue Valve is inspired by you.