CVRx has received CE mark approval from the National Standards Authority of Ireland for it Barostim neo system for the treatment of heart failure. The therapy is approved for use in heart failure patients having an ejection fraction ≤35% and a New York Heart Failure Classification of III without restriction on QRS duration, concomitant medical device treatment or presence of atrial fibrillation. The system was approved for commercialisation in Europe based on patient results from randomised, controlled clinical studies conducted in Europe, Canada and the USA.
A company press release explain that Barostim neo is a second-generation device that uses CVRx-patented technology that is designed to trigger the body’s own natural blood flow regulation system to treat patients suffering from chronic heart failure and resistant hypertension. The system works by electrically activating the baroreceptors, the body’s natural sensors that regulate cardiovascular function. By activating this afferent pathway, Barostim restores sympatho-vagal balance by reducing sympathetic activity and increasing parasympathetic activity.
“This is a tremendous milestone for CVRx. Barostim neo is the only implantable device which has received CE mark approval for patients with heart failure in addition to CE mark approval for patients with resistant hypertension. We are very encouraged with the safety, performance, and health care utilization data related to Barostim neo for both indications. We appreciate the clinical rigor NSAI used for this CE Mark approval. This places CVRx in a very unique position” said Nadim Yared, chief executive officer of CVRx.