CVRx, a medical device company, has achieved two significant milestones in its heart failure and hypertension businesses.
CVRx CEO Nadim Yared said that the company is very excited to announce that CVRx has completed enrollment of its Barostim HOPE4HF heart failure study and that the French Ministry of Health has selected Barostim Therapy for Resistant Hypertension as one of five investigator-initiated studies it will fund beginning in 2014.
CVRx completed enrollment of a 140 patient randomized, controlled clinical trial to determine the performance of Barostim Therapy for patients suffering from chronic heart failure with advanced symptoms. Patients were randomized to receive optimal medical management or Barostim Therapy plus optimal medical management.
Patients were enrolled in the US, Germany, Italy, and Canada. Results will be used to obtain regulatory approval in Europe in addition to seeking approval to conduct a larger clinical trial in the United States to enter the US market.
Results from a single center heart failure study at IRCC MultiMedica in Milan, Italy were recently presented at American Cardiology Conference (ACC) Scientific Sessions 2014 by Professor Edoardo Gronda and colleagues.
The presented data showed a significant reduction in health care utilization for his eleven patients when comparing the cumulative hospitalization of the group 12 months prior to receiving Barostim Therapy as compared to 12 months after beginning therapy.
The French Ministry of Health will Fund an Investigator-Initiated Study to Evaluate the Incremental Cost Effectiveness (ICER) of Barostim for Patients with Resistant Hypertension
The investigator-initiated medicoEconomic evaluation of baroreceptor STIMulation for the treatment of Resistant HyperTensioN (ESTIM-rHTN) study was one of five studies selected in 2014 by the French Ministry of Health for public funding and sponsored by the Nancy University Hospital (Nancy, France).
Professor Patrick Rossignol, Nancy, France, and Professor Michel Azizi, Georges Pompidou European Hospital, Paris, France, are the principal investigators. The study will randomize 128 patients to receive optimal medical management or Barostim Therapy plus optimal medical management at 13 centers designated as Hypertension Centers of Excellence across France.