Anuncia Medical has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its ReFlow® EVD. This device is designed to improve external ventricular drains (EVDs), which are used to manage brain swelling and high intracranial pressure. The recognition from the FDA marks a key milestone in Anuncia's efforts to advance CSF management technologies.
EVDs are used in over 100,000 cases annually in the United States to alleviate increased intracranial pressure. The ReFlow® EVD is the first device of its kind to include a non-invasive, manual flushing feature that restores and maintains CSF flow.
By reducing the likelihood of blockages, this innovation aims to prevent extended intensive care unit (ICU) stays, additional neurosurgical procedures, and the costly replacement of EVDs. Unlike traditional methods that require a neurosurgeon to perform flushing, the ReFlow® EVD allows trained nurses to carry out the process non-invasively during routine patient checks. This integration into existing workflows is expected to improve efficiency and reduce healthcare costs.
Anuncia has also received support from the Flinn Foundation through its Bioscience Entrepreneurship Programme to conduct post-FDA clearance studies on the ReFlow® Mini Flusher. This research is led by specialists from Phoenix Children's Hospital and HonorHealth Medical Group. The study aims to enhance hydrocephalus care, particularly for patients at high risk of shunt occlusion, including those affected by Coccidioidomycosis (Cocci) Meningitis, a serious complication of Valley Fever.
The need for better neurosurgical care also affects rural and underserved communities in the United States. With approximately 30 million people worldwide living with hydrocephalus, ensuring effective treatment remains a significant challenge. Early data from the US commercial rollout of ReFlow® suggest that the device could help prevent catheter blockages, potentially reducing the number of emergency surgeries required.
Through continued research, partnerships, and regulatory support, Anuncia is working towards broader adoption of ReFlow® as a standard treatment for hydrocephalus. This innovative CSF management solutions improve patient care and enhances neurosurgical treatment.
