Earlier this year, Anuncia Inc., a medical device company focused on the development of treatment devices for hydrocephalus and other cerebrospinal fluid (CSF) disorders, announced that the ReFlowTM System Mini received the U.S Food and Drug Administration (FDA) Breakthrough Device Designation. The ReFlowTM System Mini is the next generation version of the commercial ReFlowTM Ventricular System.
The ReFlowTM Ventricular System is composed of an in-line flusher and proprietary ventricular catheter. By simply pressing the flusher’s dome located under the scalp, a non-invasive push of the patient’s own CSF is sent towards the ventricular catheter thereby dislodging choroid plexus that may be obstructing CSF flow through the shunt system. The catheter design is unique in that it includes an ‘emergency release.’ If the flusher is unable to unblock the standard catheter holes, pressure from the fluid injection will open an additional hole in the catheter to reestablish flow.
The next generation ReFlowTM System Mini is a smaller version of the ReFlowTM Ventricular System. Its smaller size will potentially allow it to be used in a broader population (infants to elderly patients). The ReFlowTM System Mini is also being optimized for in-clinic or at-home prophylactic (preventative) flushing of the shunt catheter – that is to flush the catheter before a blockage is present.
The ReFlowTM System Mini is not yet FDA approved, but, in a preliminary US study using the original ReFlowTM Ventricular System, prophylactic flushing of the catheter showed positive results.
The Breakthrough Device Designation means that the device is eligible for prioritized FDA regulatory review and Centers for Medicare and Medicaid (CMS) Medicare Coverage of Innovation Technology reimbursement review. This means that the product could be available to consumers and covered by Medicare sooner.
To learn more, read the press release.