The US Food and Drug Administration (FDA) has granted breakthrough device designation for the M.scio system, a non-invasive, telemetric pressure measurement system aimed at managing hydrocephalus.
Developed by Aesculap in collaboration with Christoph Miethke (Miethke), the M.scio system is designed to provide continuous access to intracranial pressure monitoring in hydrocephalus patients.
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It offers a permanent, fully implantable sensor that allows continuous, long-term intracranial pressure (ICP) monitoring of cerebrospinal fluid (CSF) without the need for invasive procedures.
Aesculap corporate vice-president Bob Sowinski said: “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.”
The FDA’s designation will expedite the development and review process of the M.scio system.
Miethke CEO and founder Christoph Miethke said: “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.”
In 2020, Aesculap and Miethke launched the M.blue valve in the US for treating hydrocephalus-related headaches.
The M.blue valve is designed for various forms of hydrocephalus, and can also be customised to provide optimal therapy to patients.
Featuring an adjustable gravitational unit and a fixed differential pressure unit, the M.blue valve operates in a position-dependent manner.
