FDA approves a shunt flushing device for hydrocephalus; could defer need for surgery

Children with hydrocephalus often have shunts implanted to drain the excess cerebrospinal fluid that builds up inside their brain. Unfortunately, shunts have a tendency to plug up. This potentially life-threatening event necessitates emergency surgery to correct or replace the shunt.

“If you have a shunt, you are always worried about what might happen in the future,” says Joseph Madsen, MD^[1], a neurosurgeon at Boston Children’s Hospital. “Close to half of shunts will have a revision within the first year of implantation. About 80 percent will require a revision within 10 years.”

Last week, the FDA cleared a device originally conceived by Madsen that can potentially flush out a clogged shunt noninvasively, avoiding the need for surgery in both children and adults. The neurosurgeon or other trained healthcare professional could simply press a button at the back of the patient’s head, just under the skin, in an office setting, Madsen says.^[2][3]

Once the device, the Alivio Ventricular Catheter & Flusher System, is available from manufacturer Alcyone Lifesciences, Inc.^[4], neurosurgeons will have the option of implanting it at the same time patients are undergoing surgery to either install or repair a shunt.

In many cases, the flusher exerts enough hydraulic pressure to flush out the obstruction, as indicated by animal studies and tests^[5] in several patients undergoing shunt operations. Madsen describes the device as mimicking the cough reflex we use to clear our airways. In severe blockages, a membrane in the catheter part of the device can also open to allow cerebrospinal fluid to pass through. This video from Alcyone gives more detail:

Madsen first sketched out the idea for a shunt flusher about 10 years ago. Alcyone, a biomedical device company focused on life-debilitating neurological conditions, saw the benefit and undertook its development several years ago.