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