CVRx, Inc., a private medical device company, announced today it received CE Mark approval from the National Standards Authority of Ireland (NSAI) of the 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 commercialization in Europe based on patient results from randomized, controlled clinical studies conducted in Europe, Canada and the United States.
"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, CEO of CVRx.
"We are impressed by the results we are seeing to date with Barostim Therapy. In our single center study we documented a significant reduction in sympathetic activity which directly correlated into reduced hospitalizations.1 This is the type of standard we are looking for when treating patients with heart failure. We are elated that the therapy is now commercially available" said Professor Edoardo Gronda from IRCC MultiMedica in Milan, Italy.
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