FDA Breakthrough Device Designation to Treat Hydrocephalus

FDA Breakthrough Device Designation to Treat Hydrocephalus

There is at least some good news developing in the fight against Hydrocephalus. The U.S. Food and Drug Administration has issued a Breakthrough Device Designation for the ReFlow System Mini intended for the treatment of Cerebral Spinal Fluid disorders requiring shunting such as hydrocephalus.

The product from privately held Anuncia Inc. will now be eligible for prioritized FDA regulatory review and Centers for Medicare and Medicaid Medicare Coverage of Innovation Technology reimbursement review.

Hydrocephalus is an abnormal buildup of fluid in the cavities deep inside the brain. The excess fluid causes the ventricles to widen, and this puts pressure on the tissues within the brain and cause visible head swelling. Sadly, this condition impacts more than 1 million Americans alone.

Lowell, Massachusetts-based Anuncia has reported that as many as half of all intracranial shunts fail within the first two years. These failures as said to be due to blockages that impair cerebral spinal fluid flow requiring emergency revision surgery. Anuncia also indicated that each failure can cost more than $40,000 per incident.

Anuncia’s ReFlow System Mini can also serve a broad hydrocephalus population rather than just one group due to its size. It can treat infants with non-communicating hydrocephalus. This would also be applicable for young women with pseudotumor cerebri, as well as older patients having “treatable dementia” which can often be misdiagnosed as Alzheimer’s or Parkinson’s.

The company has noted that this breakthrough indication would allow in-clinic or at-home noninvasive prophylactic flushing to potentially prevent blockages by trained patients, caregivers, and clinicians. And due to the size and age groups mentioned, the system is applicable for patients of all sizes. Anuncia’s ReFlow System and ReFlow System Mini came with the following description:

“The current ReFlow System is FDA cleared and CE Marked for use by a qualified clinician to facilitate a safe, noninvasive retrograde fluid flush when ventriculoperitoneal shunt flow is restricted or blocked. The ReFlow System Mini is under development and not available for sale. The ReFlow System is a prescription device sold by or on the order of a physician.”

When the body functions normally, cerebrospinal fluid flows through the ventricles and bathes the brain and spinal cord and it is then reabsorbed into the bloodstream. When that normal flow or absorption of cerebrospinal fluid is blocked, a buildup of pressure may prevent the human brain from functioning properly and it can result in brain damage and may even lead to death.

According to the National Institute of Neurological Disorders and Stroke, some of the causes of hydrocephalus at birth or in babies may be inherited genetic abnormalities, complications of premature birth, or an infection such as rubella during pregnancy which can cause inflammation in the fetal brain tissue. Hydrocephalus may also develop over time due to injury or disease such as brain or spinal cord tumors, central nervous system infections such as bacterial meningitis, and injuries or strokes that lead to bleeding in the brain.

There are two current treatments for Hydrocephalus. A shunt can be surgically inserted into the brain and then connected to a flexible subcutaneous tube to drain the excess fluid into the chest cavity or into the abdomen to be absorbed by the body. The other treatment is an Endoscopic Third Ventriculostomy (ETV) which improves the flow of cerebrospinal fluid out of the brain.

According to the Hydrocephalus Association, they also confirmed that hydrocephalus affects approximately 1 million Americans of all ages and from every socioeconomic background. The group also warns that more than 370,000 U.S. service members have sustained a traumatic brain injury and that 14% of those individuals who have suffered a severe brain injury could develop hydrocephalus. The medical costs for hydrocephalus are over $2 billion per year and 1 of every 770 babies will develop hydrocephalus.

About The Author

Kendra Evans

Kendra Evans founded Inflammation Guide in April 2020. Our goal is keeping our readers informed to help them live an empowered and full life while they manage inflammation. Inflammation Guide provides a central location for breaking news and updates on prescriptions, treatments, supplements and alternative wellness solutions to give options to people living with at least one inflammatory condition.

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