Synergia Medical, a leader in optoelectronic medical devices, announced the successful implantation of its NAO.VNS system in the first two patients enrolled in the AURORA study. The procedures, which took place on September 6, 2024, at Cliniques Universitaires Saint-Luc and UZ Gent, represent a significant step forward in the treatment of drug-resistant epilepsy (DRE).
First-in-Human Implantations
The implantations were performed by Dr. Herbert Rooijakkers at Cliniques Universitaires Saint-Luc and Dr. Frank Dewael at UZ Gent. According to Synergia Medical, both patients have recovered fully two weeks post-surgery, allowing for the commencement of stimulation therapy as planned.
"We are excited to be part of this optical revolution in neuromodulation," said Dr. Herbert Rooijakkers and Dr. Frank Dewael. "This technology has the potential to transform how we treat epilepsy and other neurological disorders, offering new hope to patients who have exhausted traditional options."
The AURORA Study
The AURORA study is designed to evaluate the safety of the NAO.VNS system in patients with DRE. The study will monitor patients over a 24-month period, focusing on the incidence of device-related and procedure-related adverse events. Following the completion of the AURORA study, Synergia Medical intends to initiate a pivotal trial across Europe, the USA, and Canada to assess the efficacy of the NAO.VNS system.
MRI Compatibility and Personalized Treatment
Prof. Dr. Kristl Vonck, Principal Investigator at UZ Gent, and Dr. Riëm El Tahry, Principal Investigator at Cliniques Universitaires Saint-Luc, highlighted the importance of the NAO.VNS system's MRI compatibility. "Ensuring full access to the benefits of MRI in healthcare is crucial, and this device offers that advantage to all our patients implanted with VNS," said Prof. Vonck. Dr. El Tahry added, "This compatibility allows us to better personalize and improve VNS therapy in the future by leveraging MRI imaging."
About the NAO.VNS System
The NAO.VNS system is a next-generation neural stimulator that aims to reduce epileptic seizures through vagus nerve stimulation (VNS). The device utilizes optoelectronic technology, minimizing metallic components and incorporating materials like quartz, polymer optical fibers, and miniaturized photovoltaic cells. This design facilitates unconditional MRI compatibility, extended battery life with rapid recharging, and enhanced cybersecurity via optical communication. The system is powered by a rechargeable battery, extending the device lifespan and enabling continuous collection of patient data through dedicated biomarkers.
The Need for New Epilepsy Treatments
Epilepsy is a common neurological disorder, affecting over 10 million adults and children in the EU and US. Approximately 30% of epilepsy patients experience poorly controlled symptoms despite conventional anti-epileptic drugs. Synergia Medical estimates that of the 220,000 new epilepsy patients diagnosed annually in the US and Europe, 66,000 have drug-resistant epilepsy, highlighting the urgent need for safe and effective treatments.
"We are thrilled with the success of these first implantations, which brings us one step closer to providing a new, innovative treatment option for patients with drug-resistant epilepsy," said Attila Borbáth, CEO and co-founder of Synergia Medical.
