Today Rhaeos, Inc. announced its initial product, FlowSense™, a wireless, noninvasive flow sensor, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). The novel technology, formed out of the award-winning John A. Rogers Research Group at Northwestern University (Evanston, IL), is designed to rapidly monitor ventricular shunt function in patients with excess cerebrospinal fluid caused by hydrocephalus. The Breakthrough Device Designation is supported by data from several recently published studies demonstrating effective use of FlowSense in detecting changes in cerebrospinal fluid volume and flow. By receiving this designation, Rhaeos will work in close collaboration with the FDA to streamline the market clearance process of FlowSense for this high-risk patient population.
“Shunt failure in patients with hydrocephalus is always a possibility and can happen at any time; it can be life-threatening. Unfortunately, today’s diagnostic tools are incomplete, at times making it difficult to determine the presence of a shunt failure,” stated Sandi Lam, MD, MBA, Division Head of Neurosurgery at Ann & Robert H. Lurie Children’s Hospital of Chicago and Professor of Neurological Surgery at Northwestern University Feinberg School of Medicine. “FlowSense noninvasively detects cerebrospinal fluid shunt flow, which can potentially eliminate delays with diagnostic testing and expedite appropriate triage and treatment for patients.”
Hydrocephalus affects over 1 million Americans today, many of whom are children. Roughly 50% of neurosurgically implanted shunts, the standard treatment used to manage the disease, fail within the first two years of shunt placement and repeated neurosurgical operations are often required. Traditionally, ventricular shunt failure is diagnosed by computed tomography (CT) and magnetic resonance imaging (MRI), which can be inconclusive, expensive, and expose patients to radiation in the case of CT scans; hospital admissions for observation also lead to high healthcare utilization. FlowSense is designed to overcome the challenges of suboptimal testing by employing a noninvasive, thermal sensor that is placed at bedside on a patient’s neck, overlaying the shunt, to detect the flow of cerebrospinal fluid. Critical data on shunt functionality is detected in under 5 minutes and wirelessly transmitted to a mobile app to improve clinical decision making. A preliminary validation study was done under the supervision of Tord Alden, MD, pediatric neurosurgeon, and Chief Medical Informatics Officer at Lurie Children’s Hospital.
“FlowSense represents a significant leap forward in hydrocephalus management and treatment,” stated Amit Ayer, MD, MBA, Chief Neurosurgery Resident at Northwestern Memorial Hospital and Co-Founder of Rhaeos. “I am proud to be part of this tremendous team of clinical innovators committed to improving the care of, what are often very young patients facing this life-long illness.”
“We are extremely pleased to receive FDA Breakthrough Device Designation for FlowSense, which will help expedite the clinical and regulatory path for this valuable technology so that patients and healthcare providers have timely access to our vital device,” stated Anna Lisa Somera, MS, MBA, MPH, the CEO of Rhaeos. “We look forward to working with the FDA over the coming months to significantly improve the diagnosis and management of failed shunts and eliminate the uncertainty caused by this devastating disease.”
Rhaeos anticipates FlowSense will be available to physicians and their patients in 2021.