LOWELL, Mass., May 22, 2018 /PRNewswire/ — Anuncia, Inc., a privately-held company focused on better treatment of hydrocephalus and cerebrospinal fluid dysfunctions, announced, today, the successful first-in-human implantation of its Alivio ReFlow™ Ventricular System for treatment of hydrocephalus at Boston Children’s Hospital.
This announcement comes on the heels of receiving the EU CE Mark and US FDA Clearance of Alivio ReFlow™ Ventricular System for the treatment of hydrocephalus. The FDA 510(k) clearance and EU approval of the Alivio ReFlow™ Ventricular System permits Anuncia to commercialize the innovative technology for treatment of hydrocephalus in the US, and Europe, to provide qualified clinicians with the option of non-invasive retrograde flushing of the ventricular catheter, to unblock occluded inlet holes or open a relief membrane to restore or increase CSF flow in a non-flowing shunt.
Hydrocephalus is a condition in which an excess of CSF accumulates within the ventricles and increases pressure in the brain, resulting in a life-threatening situation. CSF shunts are implantable devices inserted by neurosurgeons to treat Hydrocephalus. Although shunts facilitate treatment for many cases, according to the Hydrocephalus Association, at least 50 percent of patients implanted with shunts suffer from shunt failures and blockages within two years, requiring repeated revision surgeries. Further, according to Sarkiss et al., 2014, 40 percent of obstructions, the leading cause of shunt failure, have been shown to occur within the first-year post surgery.
Dr. Joseph Madsen, in the Department of Neurosurgery in Boston Children’s Hospital, who is the co-inventor of Alivio ReFlow™ Ventricular System, commented, “I am delighted that my fellow neurosurgeons will have an option to intervene non-invasively when treating hydrocephalus patients who come in with complications related to ventricular shunt obstruction.”
The costs of these often-emergent, revision surgeries to restore CSF flow and alleviate painful symptoms, present a heavy emotional and financial burden to patients, families, and healthcare facilities. Though the Alivio Flusher is not intended to change standard care practices for diagnosis, treatment, or follow-up of patients with proximal catheter occlusions; it is designed to provide a non-invasive option for neurosurgeons to restore CSF flow in a non-flowing shunt, which may potentially avert emergency revision surgery.
“This first-in-patient validation of the Alivio ReFlow System marks a key milestone for Anuncia and its efforts to advance better treatment options for patients dealing with hydrocephalus and clinicians treating these patients,” said Andrew East, Director of R&D.
PJ Anand, Founder and CEO of Anuncia, commented “The #NOMOREBS campaign by the Hydrocephalus Association, which aims to raise awareness and help improve the lives of every person living with hydrocephalus (www.nomorebrainsurgeries.org), truly inspires our innovations.”
Anuncia, based in Massachusetts, is an independent privately-held company focused on developing products for better treatment of hydrocephalus and CSF dysfunctions. Anuncia was spun-off as an independent company from Alcyone Lifesciences in 2018. For more information please visit www.reflowventcath.com
SOURCE Anuncia, Inc.