US-based medical device company CVRx has obtained CE mark approval for its Barostim neo System to treat heart failure.
The therapy has received approval to treat 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.
CVRx CEO Nadim Yared said the system 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," Yared added.
The approval was based on patient results from randomized and controlled clinical studies conducted in Europe, Canada and the US.
Barostim neo is a device that features CVRx-patented technology, which is designed to activate the body’s own natural blood flow regulation system to treat patients suffering from chronic heart failure and resistant hypertension.
The system works electrically by activating the baroreceptors, and helps in restoring sympatho-vagal balance by reducing sympathetic activity and increasing parasympathetic activity.