Center Valley, PA (May 15, 2020) – Aesculap, Inc., in partnership with The Christoph Miethke GmbH & Co. KG (MIETHKE), is pleased to announce the launch of the M.blue valve, the latest generation of Hydrocephalus valve technology. Its unique gravitational technology is integrated with a fixed differential pressure unit in one valve, allowing for a simple, position-dependent solution.

The M.blue valve is the only adjustable gravitational valve in the market with an integrated fixed pressure differential valve. It provides customization of the opening pressure during the most active time of the day, i.e., the upright body position. The integration of the fixed pressure differential valve addresses the posture changes. 

“We are very pleased to be able to continue to provide healthcare teams with new and innovative solutions,” said Chuck DiNardo, President of Aesculap, Inc. “With our strong partnership with MIETHKE comes an impactful collaborative effort to bring better Hydrocephalus solutions to patients, such as the new M.blue valve.”

“The patient is our priority and we will continue to invest in research and development to create better solutions. Our focus on Hydrocephalus valves creates an expertise and openness to future developments that allows us to serve in a way that will improve the lives that we touch,” said Christoph Miethke, CEO and Founder of MIETHKE, the manufacturer of Hydrocephalus valves for Aesculap, Inc. is located in Potsdam, Germany.

According to the Hydrocephalus Association, it is estimated that over 1,000,000 people in the United States currently live with Hydrocephalus.¹ Shunt therapy is the most common way to treat Hydrocephalus, which is caused by excessive cerebrospinal fluid in the brain, causing build up and pressure that can lead to symptoms such as chronic headaches, vomiting, abnormal head enlargement and could lead to death. However, despite the shunts’ life-saving purpose, implantation has been riddled with high failure rates, causing multiple revisions and surgeries for an individual with the condition.²  Using gravitational systems have demonstrated good clinical outcomes in patients and reduced revisions compared to other valves.^3,4,5,6   

“This newest addition to the valve portfolio continues our tradition of offering uncompromised pressure adaptation through our gravitational systems,” said Odra Anderson, Product Manager for Aesculap, Inc. The M.blue valve is the smallest adjustable gravitational valve in the U.S. market. Its soft touch mechanism allows for comfortable adjustment. The design features an “active-lock mechanism” that protects from unintentional reprogramming⁷, not only after an MRI but also from everyday magnets such as smartphones⁸, toys^9,10, tablets¹¹, headphones¹², nurse badges¹³ and hearing devices^14,15. Its design is robust and durable, made with highly bio-compatible titanium,^16,17 oxidized to display a shade of blue.

Aesculap is taking the headaches out of treating Hydrocephalus with our brand new gravitational valve system. To learn more, please visit www.aesculapusa.com/thenewblueusa

_{¹https://www.hydroassoc.org/about-us/newsroom/facts-and-stats-2/
²Lutz BR, Venkataraman P, Browd SR. New and improved ways to treat hydrocephalus: Pursuit of a smart shunt. Surg Neurol Int 2013;4(Suppl 1):S38-50.
³Freimann FB, Sprung C. Shunting with gravitational valves--can adjustments end the era of revisions for overdrainage-related events?: clinical article. J Neurosurg 2012;117(6):1197-204.
⁴Tschan CA, Antes S, Huthmann A, et al. Overcoming CSF overdrainage with the adjustable gravitational valve proSA. Acta Neurochir (Wien) 2014;156(4):767-76; discussion 76.
⁵Lemcke 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;84(8):850-7.
⁶Kehler U, Kiefer M, Eymann R, et al. PROSAIKA: a prospective multicenter registry with the first programmable gravitational device for hydrocephalus shunting. Clin Neurol Neurosurg 2015;137:132-6.
⁷ https://www.aesculapusaifus.com/sites/default/files/ifus/MBlue_SOP-AIC-5002159_%28TA015577%29.PDF
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⁹Anderson RC, Walker ML, Viner JM, et al. Adjustment and malfunction of a programmable valve after exposure to toy magnets. Case report. J Neurosurg 2004;101(2 Suppl):222-5.
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¹³Fujimara R, Lober R, Kamian K, et al. Maladjustment of programmable ventricular shunt valves by inadevertent exposure to a common hospital device. Surg Neurol Int 2018;9:51
¹⁴Chadwick K, Moore J, Tye G, et al. Management of patients with cochlear implants and ventriculopertioneal shunts. Cochlear Implants International 2014;15:4, 185-190
¹⁵Pierson MJ, Wehrmann D, Albers JA, et al. Programmable shunt valve interactions with osseointegrated hearing devices. J Neurosurg Pediatr 2017;19(4): 384-390.
¹⁶Sidambe AT. Biocompatibility of Advanced Manufactured Titanium Implants-A Review. Materials (Basel, Switzerland) 2014;7(12):8168-88.
¹⁷Saini M, Singh Y, Arora P, et al. Implant biomaterials: A comprehensive review. World journal of clinical cases 2015;3(1):52-7.}