Alcyone Lifesciences Receives EU CE Mark Approval for Alivio Ventricular Catheter and Flusher System for Treatment of Hydrocephalus

News provided by

Oct 24, 2017, 09:00 ET

LOWELL, Mass., Oct. 24, 2017 /PRNewswire/ -- Alcyone Lifesciences, Inc., a leader in advanced precision delivery for neurological conditions, and innovator in the treatment of hydrocephalus, announced receipt of CE (Conformité Européenne) Mark approval for European commercialization of its Alivio Ventricular Catheter and Flusher System for the treatment of Hydrocephalus.

Hydrocephalus is a condition in which an excess of cerebrospinal fluid (CSF) accumulates in the ventricles and can increase the intracranial pressure (ICP) in the brain, creating a potentially life-threatening condition. CSF shunts are implantable devices inserted by neurosurgeons to treat hydrocephalus. Many patients are at risk of shunt failure due to ventricular catheter occlusions, many requiring numerous revision surgeries by adolescence. The cost burden of hydrocephalus management is $2Bn¹. The burden to patients and their families is immeasurable. "Hydrocephalus refers to enlargement of the ventricles and can be a result of infection, hemorrhage, neoplasm, spinal dysraphism, trauma, or a congenital etiology.² An estimated 125,000 U.S. children have shunt-dependent Hydrocephalus,² with an estimated prevalence of 1-1.5%.² Shunt failure is common; 40% of shunts fail within the first year² and 56-80% by 10 years.² Between 8-10% of shunts eventually become infected"² Shunt malfunction can lead to an acute increase in ICP, which may be a life-threatening emergency, making early detection and treatment critical to reducing morbidity and mortality."²

"Cerebrospinal fluid (CSF) shunt failures account for more than 15,000 pediatric hospital admissions per year and have an estimated mortality rate of 1-2%. The prompt recognition and treatment of shunt failure in the emergency department (ED) is of the utmost importance to limit morbidity and mortality," stated Ann M. Dietrich, MD^2, pediatric emergency medicine clinician in Columbus, OH.

Alcyone's Alivio Ventricular System, is comprised of a Flusher and Ventricular Catheter with unique relief membrane. The system, in conjunction with any CSF shunt, is designed to address one of the two most common problems with CSF shunts: namely obstructions of the ventricular catheter. To extend the life of these shunts, and avoid emergency shunt revision, retrograde flushing of flow regulating valves and invasive shunt taps have been employed by some neurosurgeons in attempt to unblock ventricular catheters. However, these methods have been inconsistent, and can introduce risk of infection (the other most common CSF shunt problem) and risk of damage to the flow regulating valve.

Dr. Joseph Madsen, associate professor for Harvard Medical School, a pediatric neurosurgeon at Boston Children's Hospital, and co-inventor of the Alivio Ventricular System, stated, "the risk of unexpected blockage of a ventricular shunt has been a major source of worry for patients and parents touched by hydrocephalus for years. This simple, biologically-inspired, solution developed by the Alcyone team will hopefully result in improved treatment and peace-of-mind for these patients and families."

Andrew East, Alcyone's director of product development, stated, "repeated emergency brain surgeries due to ventricular shunt occlusions severely impacts the patients and families dealing with hydrocephalus, which is unacceptable and there is a real need for a better solution for patients and clinicians treating these patients. We are thrilled to be able to achieve the objective to provide a simple yet elegant solution designed to help prevent these invasive emergency brain surgeries. We hope this will improve the lives of those suffering from hydrocephalus. We are excited to receive this CE Mark approval for Europe and we're looking forward to working with clinicians committed to providing superior solutions for improved treatment of hydrocephalus."

About Alcyone Lifesciences, Inc.
Alcyone Lifesciences, based in Lowell, Massachusetts, is a privately-held medical device company focused on development of novel treatment modalities for chronic neurological conditions including hydrocephalus and CNS gene and antisense therapy for rare and orphan disorders. The Company's patented technology platforms are based on a uniquely engineered amalgamation of microfabrication technologies along with advanced biomedical engineering with biologically inspired core product focus on targeted drug therapy and hydrocephalus treatments. Alcyone's team of scientists, engineers, physicians and advisers includes recognized leaders in the field of neurology and neurosurgery. For more information, please visit www.alcyonels.com

Contacts
Alcyone Lifesciences, Inc.
PJ Anand, 978-709-1946
Chief Executive Officer
[email protected]

Sources:
1 http://www.hydroassoc.org/docs/Hydro_Why_FactSheet_v1.04.pdf

2 https://www.ahcmedia.com/articles/136133-cerebrospinal-fluid-shunt-emergencies

SOURCE Alcyone Lifesciences, Inc.