Hydrocephalus Association Network for Discovery Science (HANDS) is working to make prevalence rates…
On August 2, 2016, Alcyone Lifesciences, Inc., a medical device company focused on the development of treatment devices for hydrocephalus and other neurological conditions, announced the clinical use of its ReFlowTM System in a study at Boston Children’s Hospital (BCH).
What is this device and what is it designed to do?
The purpose of the ReFlowTM System is to reduce emergency risks associated with a blocked ventricular catheter. The ReFlowTM system is composed of an in-line flusher reservoir and proprietary ventricular catheter and is compatible with commercially available flow regulating valves and accessories. The flusher is designed to non-invasively discharge fluid towards the ventricular catheter thereby dislodging choroid plexus that may be obstructing cerebrospinal fluid (CSF) flow through the shunt system. The catheter design is unique in that it includes an ‘emergency release.’ If the flusher is unable to unblock the standard catheter holes, the pressure from the fluid injection will open an additional hole in the catheter to re-establish flow.
Currently, investigators at BCH are testing the flusher in patients already scheduled for a shunt revision. The ultimate goal, however, is to clinically implement the fully implantable system, which is a noninvasive way to reestablish fluid flow and prevent the need for an immediate emergency shunt revision. This means that the ReFlowTM System would be implanted during an initial shunt surgery. If the patient began to have symptoms consistent with a shunt obstruction, the flusher would be activated, non-invasively, by a qualified healthcare professional.
As reported by PR Newswire, Dr. Joseph Madsen, neurosurgeon, co-inventor and pre-clinical investigator, said, “It is encouraging that the ReFlowTM System works in the operating room just as it does in bench top and animal studies. This pilot study is set to collect pressure and flow rate measurements in order to determine the safety of ’flushing‘ an existing ventricular shunt catheter.”
Dr. Benjamin Warf, the principal investigator, stated, “This is a simple and intuitive idea, and I am very hopeful that it will benefit many children by reducing shunt problems.”
Clinical Trial and FDA Submission
The official title of the study is Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters, with Dr. Benjamin Warf, Dr. Joseph Madsen and Dr. Tomer Anor from BCH as the investigators. The objective of this pilot study is to collect flow rate measurements in order to determine the safe “flushing” of a ventricular shunt catheter. A premeasured amount of saline injection volumes are being used to flush the shunt catheter using the ReFlowTM in-line Flusher. Pressure recordings of the injected fluid are recorded and monitored throughout the study. Based on the study’s objective and characteristics, the Food and Drug Administration (FDA) classifies this study as a Phase 3 trial. Phase 3 trials gather information about safety and effectiveness by studying different populations and dosages.
Alcyone has now filed a 510 (k) Premarket Notification to the FDA for commercial approval of the ReFlowTM System. If approved, the investigators could begin studying the effectiveness of the fully implantable the ReFlowTM System in hydrocephalus patients.
For more information on the on-going BCH clinical study, please visit ClinicalTrials.gov and search for NCT 02651337.
News Stories on the ReFlowTM System
Welcome to hydrocephalus researchers! Based on resounding feedback from basic scientists at the two most recent NIH hydrocephalus research workshops, the Hydrocephalus Association is establishing the Hydrocephalus Association Network for Discovery Science (HANDS). HANDS will provide a virtual and physical places for basic scientists to connect and collaborate on novel research hypotheses of interest to the hydrocephalus community. HA will provide collaboration infrastructure and support for meetings of working groups within the network. The goal will be to work together to apply for NIH funding for breakthrough scientific ideas to advance the field for hydrocephalus. Go to our membership page to sign up.
Annual Meeting of the Society for Research into Hydrocephalus and Spina Bifida
June 29-July 2
The annual SRHSB meeting will be held on June 29-July 2, 2016 in Stirling, Scotland. Andy Wynd and his local organizing committee are putting together a wonderful scientific and social programme.
The SRHSB is focused on increasing public awareness of hydrocephalus and spina bifida and to promote research across the diverse fields of study relevant to these conditions, with the ultimate goal of alleviating, managing and preventing the conditions. The research interests of SRHSB have a broad range from fetal imaging, termination of pregnancy and neonatology, to normal pressure hydrocephalus in the older population.
SRHSB website: https://www.srhsb.com/conferences/stirling-2016
- First week of January, 2016
- Abstract submission open
- Norman and Margaret Guthkelch Award submission open
- 2016 Casey Holter Essay Prize submission open
- Registration details
- Abstract submission deadline: February 26, 2016
- Norman and Margaret Guthkelch Award application deadline:February 26, 2016
- 2016 Casey Holter Essay Prize application deadline:February 26, 2016
- Abstracts and Guthkelch applications reviewed at the Executive Committee meeting:March 12, 2016
- Presentation and Guthkelch finalists notified:March 15, 2016
- Discounted early pre-registration and accommodation deadline:May 15, 2016
- Non-discounted pre-registration deadline: June 15, 2016
Hydrocephalus Association Grants
Innovator Awards: Hydrocephalus Therapeutics Research
This opportunity has passed.
The Hydrocephalus Association is soliciting applications from investigators for Innovator Awards to be used for understanding disease mechanisms and the identification and pre-clinical testing of therapies to prevent or reverse all forms of hydrocephalus. The goal of this initiative is to provide seed funding for bold and innovative research with the potential to transform the field of hydrocephalus through the understanding of disease mechanisms and the development of novel therapies.