CVRx® Announces that the First Two Patients were Treated in the Phase III Pivotal Trial Evaluating BAROSTIM THERAPY® for the Treatment of Heart Failure

MINNEAPOLIS, CVRx, a global medical device company, today announced that the first two patients have been treated with the BAROSTIM NEO^® System in the BaroreflexActivation Therapy for Heart Failure Pivotal Clinical Trial (BeAT-HF).  The procedures were done at theUniversity of California San Francisco and Abrazo Arizona Heart Hospital in Phoenix, Arizona.  More than 20 patients have been enrolled and are being evaluated for eligibility.

BeAT-HF is a Phase III randomized, controlled clinical trial that studies the safety and efficacy of BAROSTIM THERAPY, the only therapy that is designed to simultaneously reduce sympathetic nervous system activity while restoring parasympathetic activity, for the treatment of heart failure.  The trial will randomize 480 patients who suffer from heart failure with a reduced ejection fraction and who have no additional treatment alternatives available.  BeAT-HF has achieved Expedited Access Pathway (EAP) designation by FDA for its focus on this unmet clinical need.  

"We are very excited by the enrollment and treatment of the first patients in the BeAT-HF Pivotal Clinical Trial.  The patients we are including suffer from a very poor quality of life and an increased risk of heart failure-related hospitalizations, and they have no further treatment options," said Michael Zile, M.D., Professor of Medicine at the Medical University of South Carolina and Chair of the BeAT-HF Executive Steering Committee.  "BAROSTIM THERAPY has already demonstrated unprecedented symptom improvement through HOPE4HF, a Phase II randomized, controlled clinical trial, and we are looking forward to similar patient outcomes during BeAT-HF.

Source:  CVRx, Inc.