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

A new shunt-flushing device flushes out shunt blockages noninvasively.
Brain shunts frequently clog up, requiring surgical repair or replacement. A new device flushes out the blockages with the press of a button. (Wikimedia/Adobe Images)

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.

Joseph Madsen, MD, co-developer of the Alivio shunt flusher
Madsen

“They’ve done a great job moving things ahead,” says Madsen. “It’s now available for implanting into patients, and will hopefully restore peace of mind to thousands of patients with hydrocephalus and their families.”

Madsen envisions someday pairing the Alivio system with a related device he’s developed called ShuntCheck[6] that can check for shunt blockage, under development by another company called NeuroDx[7].

More on the Alivio system in the company’s press release[8] and this blog from the Hydrocephalus Association[9].

References

  1. ^ Joseph Madsen, MD (www.childrenshospital.org)
  2. ^ cleared (www.fda.gov)
  3. ^ device (www.alcyonels.com)
  4. ^ Alcyone Lifesciences, Inc. (www.alcyonels.com)
  5. ^ tests (clinicaltrials.gov)
  6. ^ ShuntCheck (vector.childrenshospital.org)
  7. ^ NeuroDx (neurodx.com)
  8. ^ company’s press release (www.prnewswire.com)
  9. ^ this blog from the Hydrocephalus Association (www.hydroassoc.org)

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