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.”