CVRx® Barostim Therapy® for Heart Failure Clinical Trial Results Presented in the Late-Breaking Clinical Trial Session of the Heart Rhythm Society 2015 Annual Conference

MINNEAPOLIS, 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."

About Barostim Therapy

CVRx completed a 146-patient randomized, controlled clinical trial to determine the performance of Barostim Therapy for patients suffering from chronic heart failure with advanced symptoms.  Aggregate results were recently presented at the American College of Cardiology's (ACC) Annual Scientific Session and simultaneously published in JACC-HF.  Barostim Therapy was shown to be safe and significantly improved patient functional and exercise capability, as well as quality of life, when compared to optimal medical therapy.  Barostim Therapy also significantly reduced the plasma biomarkers of heart failure severity and the burden of heart failure hospitalizations in patients with heart failure.

About Barostim neo

Barostim neo is a second-generation device that uses CVRx-patented technology designed to trigger the body's own natural blood flow regulation system to treat patients suffering from chronic heart failure.  The therapy is also a treatment option for patients with resistant hypertension.  The system electrically activates the baroreflex, the body's natural mechanism to regulate cardiovascular function.  By activating this afferent pathway, Barostim Therapy reduces sympathetic activity and increases parasympathetic activity, ultimately restoring sympatho-vagal balance.

Key unique benefits:

  • The Barostim neo can be turned on and off to demonstrate acute results 
  • It can be adjusted to meet each patient's individual therapy needs 
  • It is a reversible treatment, the therapy can be turned off 
  • It provides 100 percent adherence to treatment by continuously activating the baroreflex 
  • It is compatible with and complementary to implantable cardiac rhythm management devices

Source:  CVRx, Inc. 

 

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