Alcyone Lifesciences is seeking formal commercial approval for its device to treat fluid buildup in the brain, following its successful implant in 4 patients in an ongoing study at Boston Children’s Hospital.
The Lowell, Mass.-based company said that its decision to file a 510(k) premarket notification with the FDA seeking a regulatory sign-off for its ReFlow System also comes after the successful completion of a number of bench and animal studies.
Alcyone wants to treat a condition known as hydrocephalus, where there is an excessive buildup of cerebrospinal fluid. As the company explains, this can threaten a patient’s life as it puts too much pressure on the brain. The condition typically hits young children and can leave them with an enlarged head, creating risks for brain damage.
Alcyone is hoping ReFlow will be a better option than existing shunts implanted to treat the condition, for which young patients in particular are at high risk for shunt failure due to blockage.
ReFlow consists of a flusher and ventricular catheter, and what it calls a “relief membrane.” This combined cerebrospinal fluid shunt system is designed to avoid emergency shunt revision surgery through the use of its flusher, which is intended to keep the catheter unblocked. Dr. Joseph Madden, a Boston Children’s Hospital pediatric neurosurgeon who invented some of the ReFlow patents, described the device as restoring catheter flow by mimicking the cough reflex.
The four patients treated so far with ReFlow are part of an institutional review board-approved study at Boston Children’s Hospital.
This pilot study began in March and is expected to run through January 2017. Plans call for enrolling up to 30 patients. Subjects in the study can be from 1 month old to 35-years of age, according to clinicaltrials.gov.