Hallo! Allow me to first introduce myself. My name is Nicola, and I work at fischerAppelt, Spectrum’s partner PR agency in Germany. Currently, I’m in Washington as part of GLOBALHealthPR’s ongoing exchange program among its partners.
Last Friday, I attended a meeting with the Neurological Device Panel of the FDA Medical Devices Advisory Committee. The panel came together to advise the FDA on the Premarket Approval Application of a new medical device to treat epilepsy. This device, the RNS System from NeuroPace, uses responsive neurostimulation to monitor and interrupt abnormal electrical activity in the brain before seizures occur. It is supposed to be a new treatment option for patients that had previously been treated with two or more anti-epileptic drugs without achieving seizure control and who are not suitable candidates for surgery.
The meeting showed how different views can reveal very diverse perspectives on a topic. The meeting started at 8am with the sponsor, NeuroPace, providing a well-prepared and well-timed presentation. Afterward, FDA representatives explained their view on the data – which was a rather long reading of facts and figures – and rounded out the presentation with important information regarding the product’s safety.
After the lunch break, the open public hearing started. I have to say, it was quite emotional and moving. Among other presenters, three patients described their lives before and after the implantation of the RNS System and how it changed everything; how they have been able to participate in everyday activities they weren’t able to before and how they can now take responsibility for themselves. Their stories showed how powerful individual and personal perspectives and real-life experiences are, leaving the audience visibly stunned at certain points.
A discussion about the effectiveness and safety of the RNS System followed in the afternoon before the experts were asked about their opinion of different data aspects and details. In the end, the expert panel voted in favor of the new device.
Attending the FDA Advisory Committee Meeting was a very interesting experience for me – as was my entire trip to Washington, D.C. This is a fascinating city and, as I have come to learn, it’s best explored on foot! I also have noticed people here are very active and running is very popular (and people run in shorts – even when it’s 0°C!). And of course, I have picked up some interesting insights into healthcare PR in the U.S. and helpful inspiration to bring back to Germany.
Last but not least, I’d like to thank the people here at Spectrum for welcoming me and taking time to share their experiences! I look forward to continuing and deepening this exchange in the future.
Auf Wiedersehen, Washington!
