CVRx’s Barostim Neo Device Receives the US FDA’s Approval as World’s First Heart Failure Neuromodulation Device

CVRx’s Barostim Neo Device Receives the US FDA’s Approval as World's First Heart Failure Neuromodulation Device

Shots:

  • The US FDA’s PMA is based on P-III BeAT-HF study confirming the safety of Barostim Neo and its effectiveness in improving symptoms in 264 patients with chronic heart failure. The 130 patients were randomized to receive Barostim Neo vs remaining to stay on guideline-directed medical therapy
  • The P-III BeAT-HF study results:  improvement in QoL score by 14 points using the Minnesota Living with Heart Failure Questionnaire, improvement in exercise capacity by 60 meters as measured by the 6-minute hall walk test, and improvement in their functional status as assessed by their NYHA classification, reduction in NT-proBNP
  • Barostim Neo utilizes CVRx technology act by triggering the body’s cardiovascular reflex by electrically activating the baroreflex thus reduces sympathetic activity and increases parasympathetic activity, therefore restoring autonomic balance

Click here to­ read full press release/ article | Ref: Business Wire | Image: Radcliffe Cardiology