CVRx has received humanitarian device exemption (HDE) approval from the US Food and Drug Administration (FDA) for its Barostim neo legacy device.
This decision represents CVRx’s first commercial approval in the USA and is based on a determination by the FDA that neo legacy is safe and can be used in US patients who were defined as responders to the Rheos Carotid Sinus Lead System.
“We are excited that our early clinical subjects who are actively being treated in our hypertension feasibility and pivotal studies will be able to maintain access to continued therapy through the HDE approval. All of these patients have been treated for over five years with Barostim Therapy,” says Nadim Yared, chief executive officer of CVRx.
