Anuncia has announced that it has received US Food and Drug Administration (FDA) breakthrough device designation for its ReFlow system mini, intended for the treatment of cerebral spinal fluid (CSF) disorders requiring shunting.
Elsa Abruzzo, president of Anuncia, stated: “Our team is very pleased to achieve this significant milestone making the ReFlow system mini eligible for prioritised FDA regulatory review and Centers for Medicare and Medicaid (CMS) Medicare Coverage of Innovation Technology (MCIT) reimbursement review.”
According to Anuncia, as many as half of all intracranial shunts fail in the first two years, mainly due to blockages that impair CSF flow requiring emergency revision surgery, each costing upwards of US$40,000.
“The ReFlow system mini is optimised to serve a broad hydrocephalus population—infants with non-communicating hydrocephalus, young women with pseudotumor cerebri, and older patients with communicating, idiopathic normal pressure hydrocephalus (iNPH). iNPH is known as the treatable dementia and is often misdiagnosed as Alzheimer’s or Parkinson’s,” commented Mark Luciano, director of the Cerebral Fluid Center and professor of Neurosurgery at Johns Hopkins University, Baltimore, USA.
Anuncia states that in a preliminary study of patients at risk for shunt occlusion by two US paediatric centres, all intracranial shunts remained patent beyond one year using prophylactic flushing with the current ReFlow system and more than half of the patients are nearing their two-year, occlusion-free shunt anniversary.
Ramin Eskandari, chief of Pediatric Neurosurgery at the Medical University of South Carolina, Charleston, USA, remarked: “The ReFlow system mini is unique in that it could be used with any newly implanted or revised shunt system in any size patient. Coupled with at-home, noninvasive prophylatic flushing, the ReFlow system mini may decrease emergent hospitalisations, reduce patient and healthcare system costs, and improve the everyday quality of life and overall clinical outcomes for these vulnerable patients living with hydrocephalus.”