CVRx’s Barostim Therapy Receives Expedited Access Pathway Designation
Medical device firm CVRx has received expedited access pathway designation from the FDA for its Barostim therapy for the treatment of heart failure.
The minimally invasive implantable device is designed to trigger the body's natural blood flow regulation system. It electrically activates the baroreflex, the body's natural mechanism to regulate cardiovascular function.
Barostim also is an option for patients with treatment-resistant hypertension.
Results from a 146-patient clinical trial of the device showed significant improvement in patient symptoms, functional capacity and cardiovascular function, the company says. — Michael Cipriano