Alcyone Lifesciences Receives FDA Clearance for the Alivio System for the Treatment of Hydrocephalus
LOWELL, Mass., Nov. 15, 2017 /PRNewswire/ -- Alcyone Lifesciences, Inc., announced that the U.S. Food and Drug Administration (FDA) cleared the Alivio Ventricular Catheter & Flusher System (Alivio System) for the treatment of hydrocephalus. This comes on the heels of Alcyone receiving the EU CE Mark last month. The FDA 510(k) clearance and EU approval permit Alcyone Lifesciences to commercialize the Alivio System 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 cerebrospinal fluid (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 Association1 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.
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.
"For the first time in over half a century there has been a game changing improvement in the field of hydrocephalus treatment. Ventricular shunting can help save lives and improve the quality of life that otherwise most patients with hydrocephalus would never experience. However, shunt failures can be abrupt, without warning, carry significant morbidity, and be life-threatening," stated Ramin Eskandari, M.D., assistant professor, pediatric neurosurgery, Medical University of South Carolina. "The implantation of Alcyone's new Alivio Shunt System will enable neurosurgeons with the ability to provide emergency treatment during shunt malfunctions, delivered completely non-invasively, preventing neurological decline and allowing time for patients to reach definitive neurosurgical care."
"Patients and families dealing with hydrocephalus deserve a better quality of life and It is our hope that the Alivio System will provide peace-of-mind to these patients, and families, living in fear and worry of potential abrupt shunt occlusions," stated PJ Anand, founder and chief executive officer of Alcyone Lifesciences. "We are grateful to the patients and families with hydrocephalus, and clinicians treating these patients, for the encouragement and support. We are excited to launch this product in the US and EU early in 2018."
"We are tremendously excited about the FDA clearance of this new technology focused on potentially reducing the number of emergency surgeries that may be required for members of our community," said Diana Gray, MA, president and chief executive officer of the Hydrocephalus Association. "The Hydrocephalus Association is committed to finding a cure and improving the lives of people living with hydrocephalus through research, advocacy, education and support services."
About the Alivio System
The Alivio System, is comprised of a Flusher and Ventricular Catheter (VC) with a unique relief membrane. The system, in conjunction with any CSF shunt flow regulating valve and drainage catheter, is designed to address one of the two most common problems with CSF shunts -- obstructions of the ventricular catheter. To extend the life of these shunts, and avoid emergency shunt revision, retrograde flushing using 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 shunt taps can introduce risk of infection (the other most common CSF shunt problem) and risk of damage to the flow regulating valve.
Alcyone worked closely with FDA during their thorough and thoughtful review of the Alivio System, and looks forward to being able to help patients, who suffer from hydrocephalus and have had numerous emergency surgeries due to blocked ventricular catheters. With FDA 510(k) clearance of the Alivio System, Alcyone is hopeful it can help clinicians offer expanded treatment options to these patients. This core concept of a fully implantable and non-invasive treatment designed to consistently unblock an occluded VC originated from results of an earlier clinical evaluation performed at Boston Children's Hospital (BCH), where the flushing concept was studied on VCs undergoing revision due to occlusions and then also flushed successfully to improve flow using the Alivio Flusher. BCH, along with Dr. Joseph Madsen, who is a pediatric neurosurgeon at BCH and a scientific advisor to the company, closely collaborated with Alcyone to advance the concept into a viable technology.
"After decades of implanting VP shunts to treat children with hydrocephalus, and after performing many hundreds of shunt revisions, many of them in emergency, life-or-death situations, I am very impressed with the simple and elegant way the Alcyone team has produced a device platform, which restores flow in a blocked shunt for a child or adult depending on a flowing shunt," stated Dr. Madsen. "Akin to the coughing reflex we all depend on to clear our breathing pathways, a non-invasive way to reopen a blocked shunt will hopefully restore peace-of-mind to thousands of patients with hydrocephalus and their families."
We aim to educate Hydrocephalus patients and families about the system, treatment options, and other conditions associated with Hydrocephalus through our newly launched patient-oriented website. (www.ReflowVentCath.com)
About Alcyone Lifesciences, Inc.
Alcyone Lifesciences, based in Lowell, Massachusetts, is a privately-held therapy-enabling biomedical device company focused on development of novel treatment modalities for rare, orphan and life-debilitating neurological conditions. The company's Alivio System for the treatment of hydrocephalus has been approved in both the US and EU. For more information, please visit www.reflowventcath.com.
SOURCE Alcyone Lifesciences, Inc.