We are excited to announce we received our second Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the eShunt System.
The Breakthrough Device Designation is for the treatment of communicating hydrocephalus in pediatric patients aged 12 and older, and was supported by data generated during our pilot clinical studies of the device, as well as original research published in the
@JNIS_BMJ
“The recognition of Breakthrough Device Designation for the eShunt System in pediatric aged patients demonstrates the profound need for treatment innovation in this patient population and reinforces the potential safety and efficacy benefits that have already been observed with this minimally invasive, endovascular approach,” said Daniel Levangie
We look forward to continuing our collaboration with the FDA and our partners as we explore next steps in potentially shifting the standard of care for this critical patient population.
prnewswire.com/news-releases…
#NPH #hydrocephalus #eShunt