CVRx® Announces Expedited Access Pathway Designation By FDA for Barostim Therapy® for the Treatment Of Heart Failure In Order To Accelerate Access for US Patients

MINNEAPOLIS, CVRx, Inc., a private medical device company, announced that it received Expedited Access Pathway (EAP) Designation by FDA for Barostim Therapy^® for the treatment of heart failure. The EAP designation is based on Barostim Therapy being intended to treat a life-threatening or irreversibly debilitating disease where there is no available treatment alternative.  This groundbreaking initiative, recently launched by FDA, is intended to significantly accelerate access for US patients and their physicians to innovative medical treatments. 

The EAP Designation applies to CVRx's Phase III randomized, controlled clinical trial, Baroreflex ActivationTherapy for Heart Failure Pivotal Clinical Trial (BeAT-HF). CVRx is currently completing the selection and training of clinical investigative centers to participate in the trial.

"We applaud FDA for creating the EAP Designation. This comes at a critical time for heart failure physicians, who are actively looking for treatment options for patients who are not adequately managed with current guideline-directed therapies", said Dr. William Abraham, Director of the Division of Cardiovascular Medicine at The Ohio State University Wexner Medical Center.  "Barostim Therapy is designed to activate the Baroreflex through the afferent (sensory) pathway causing a simultaneous reduction in sympathetic activity and increase in parasympathetic activity. Restoring autonomic balance leads to a reduction in symptoms and has the potential to significantly improve cardiovascular function and patient outcomes. This mechanism of action is unique to Barostim Therapy when compared to other neuromodulation-based therapies." 

Source: CVRx, Inc.