US-based medical device firm CVRx has received CE Mark approval from the National Standards Authority of Ireland (NSAI) for the Barostim neo system to treat heart failure patients.
The Barostim neo system is for patients having an ejection fraction less than or equal to 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 is approved for commercialisation in Europe based on patient results from randomised, controlled clinical trials carried out in Europe, Canada and the US.
A total of 140 patients were enrolled in a clinical trial to determine the performance of Barostim Therapy for patients suffering from chronic heart failure with advanced symptoms.
The company has also presented and published positive results from an earlier trial showing clinical improvement and reduced hospitalisations.
Currently, the six-month results from the randomised, controlled trial are being prepared for publication.
CVRx CEO Nadim Yared said: "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 utilisation 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."
The company has also reported results of the 322-patient sham-controlled Rheos Hypertension trial, which showed a statistically significant reduction of systolic and diastolic blood pressure in excess of 32mmHg and 17mmHg, respectively, over the course of a five-year period.
In addition, the long-term safety profile of the therapy proved to be excellent with very low rates of stroke, myocardial infarction and worsening of carotid stenosis in this population of patients with advanced hypertension.
IRCC MultiMedica professor Edoardo Gronda said: "We are impressed by the results we are seeing to date with Barostim Therapy.
"In our single centre study, we documented a significant reduction in sympathetic activity, which directly correlated into reduced hospitalisations.
"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."
Barostim neo is a second generation device that uses the company’s 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 device works by electrically activating the baroreceptors, the body’s natural sensors that regulate cardiovascular function.