CVRx, Inc., a privately held medical device company, announced that it has received Humanitarian Device Exemption (HDE) approval from the US Food and Drug Administration (US FDA) for its Barostim neo legacy device. This milestone represents CVRx's first commercial approval in the United States and is based on a determination by the FDA that neo legacy is safe and can be used in US patients who were defined as responders to the Rheos Carotid Sinus Lead System.
"We are excited that our early clinical subjects who are actively being treated in our hypertension feasibility and pivotal studies will be able to maintain access to continued therapy through the HDE approval. All of these patients have been treated for over five years with Barostim Therapy, said Nadim Yared, chief executive officer, of CVRx. "During that time, CVRx has remained committed to providing access to Barostim Therapy for patients. My team and I want to thank our investigators, clinical research coordinators, investors, and especially our pioneering patients for their commitment to the therapy. We also want to thank FDA for interactively working with us on this unique approval."
Five-year results of the 322-patient sham-controlled Rheos Hypertension Trial were presented at the American Society of Hypertension and the joint European and International Societies of Hypertension annual scientific conferences in May and June of 2014. The results showed a persistent and statistically significant reduction of systolic and diastolic blood pressure in excess of 32mmHg and 17mmHg, respectively, over the course of 5 years. 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.
Barostim Therapy is included in the joint European Society of Hypertension and European Society of Cardiology guidelines for the treatment of resistant hypertension that were published in June, 2013.
CVRx has completed 6 month follow-up in a 146 patient randomised, controlled clinical trial to demonstrate the performance of Barostim Therapy in patients suffering from chronic heart failure with advanced symptoms. Promising results from an earlier study demonstrating clinical improvement and reduced hospitalisations have been presented and published. The six month results from the randomised, controlled trial are being prepared for publication.