Christoph Miethke GmbH
M.scio
Aesculap Inc (Aesculap) and Christoph Miethke GmbH & Co (Christoph Miethke) have been granted Breakthrough Device designation by the US Food and Drug Administration (FDA). The award is regarding the duo’s non-invasive, telemetric pressure measurement system, the M.scio System. The Breakthrough Device Program aids with the development and review of medical devices.
According to the developers, the solution provides continuous access to long-term, intracranial pressure (ICP) monitoring of cerebrospinal fluid (CSF) management of hydrocephalus. This is achieved through the use of a permanent, fully implantable sensor.
“The Breakthrough Device Designation is an important step forward toward recognising the need for equipping neurosurgeons with an innovative technology to improve care for hydrocephalus patients in the US,” said Bob Sowinski, Corporate Vice President of 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.”
“Advances in shunt technology, particularly adjustable gravitational valves, have significantly improved patient outcomes,” concludes 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 optimise 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.”