FDA Grants Aesculap Breakthrough Device Designation for the M.scio® Non-Invasive Telemetric Pressure Measurement System

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Aug 27, 2024, 09:16 ET

A Novel System for Monitoring Intracranial Pressure in Hydrocephalus Patients

CENTER VALLEY, Pa., Aug. 27, 2024 /PRNewswire/ -- Aesculap, Inc. (Aesculap), in partnership with Christoph Miethke GmbH & Co. KG (MIETHKE), announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the M.scio^® System. This unique, non-invasive, telemetric pressure measurement system is designed to provide continuous access to long-term, intracranial pressure (ICP) monitoring of cerebrospinal fluid (CSF) for the management of hydrocephalus via a permanent, fully implantable sensor.

The Breakthrough Device Program is a voluntary program designed to expedite the development and review of medical devices that may provide more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease. Receiving this designation is a testament to the joint commitment of Aesculap and MIETHKE to improve the lives of patients living with hydrocephalus.

"The Breakthrough Device Designation is an important step forward toward recognizing the need for equipping neurosurgeons with an innovative technology to improve care for hydrocephalus patients in the U.S.," said Bob Sowinski, Corporate Vice President, Aesculap. "The current approach to ICP monitoring has limitations that the M.scio System is designed to overcome. Receiving this designation from the FDA is an acknowledgement from the agency that the device has the potential to provide a more effective treatment than existing options."

Hydrocephalus is a condition characterized by a buildup of fluid in the brain that affects mostly babies, but it can affect people at any age. It is estimated that two out of every 1,000 babies are born with hydrocephalus. If left untreated, it can lead to serious consequences, including learning or physical disabilities and even death.¹

"Advances in shunt technology, particularly adjustable gravitational valves, have significantly improved patient outcomes," said Christoph Miethke, CEO and founder of MIETHKE. "However, adjusting valves without knowing the ICP values based on a patient's body position can lead to incorrect valve adjustments. The M.scio System is designed to provide an alternative treatment option to the currently available ICP monitoring modalities. In this way, the M.scio System is designed to guide both surgical as well as medical treatment and optimize patient management. MIETHKE strives to develop technologies that enable all hydrocephalus patients worldwide to live a normal life. That's what matters and what drives us to innovate and challenge the status quo."

About Aesculap, Inc.

Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for neurosurgery, general surgery and sterilization technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients' lives. For more information, call 800-282-9000 or visit aesculapusa.com.

About Christoph Miethke GmbH & Co. KG
Since 1992, MIETHKE has been developing and manufacturing neurosurgical implants, especially for the treatment of hydrocephalus. Our vision is to develop technologies that enable all hydrocephalus patients worldwide to live a normal life. Every step in this direction is the right one and drives us to continue with further research, to make products even better and to question solutions again and again. We listen carefully to our partners, neurosurgeons and patients as well as to each other in order to learn and allow room for ideas. We are aware of the importance of our work for patients' lives and share this responsibility. For more information, call +49 331 620830 or visit miethke.com.

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