CVRx, Inc., a private medical device company, announced that positive results from the 'Barostim Therapy for Heart Failure' randomized, controlled clinical trial were presented at the 2015 annual Scientific Sessions of the Heart Rhythm Society (HRS) in a Late-Breaking Clinical Trial Session. Results were presented by Dr. Michael Zile from the Medical University of South Carolina.
Safety and efficacy results comparing patients previously treated with Cardiac Resynchronization Therapy (CRT) to patients without CRT (no-CRT) were presented. At six months in the no-CRT group, Dr. Zile reported that Quality of Life scores significantly improved, six-minute hall walk distance and left ventricular ejection fraction significantly increased, and heart failure hospitalizations were significantly reduced in Barostim Therapy patients compared to controls. "The results of the study are remarkable", Dr. Zile said. "These data are not sufficient to rule out a therapeutic effect in CRT patients, but the effect was more pronounced in patients without CRT."
"The positive results from our randomized, controlled clinical trial were well-received at HRS", said Nadim Yared, CEO and President of CVRx. "There is a significant unmet medical need for patients with advanced, chronic heart failure despite having received guideline-directed therapies, and in particular, for those patients who are not candidates for CRT."
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