Clinical outcomes in patients with chronic heart failure (CHF) have improved as a result of new medications and implantable medical devices introduced over the past few decades. However, patients diagnosed with CHF continue to experience excess mortality owing to the progressive nature of cardiovascular disease, including dysregulation of the autonomic nervous system.
Clinical evaluation of ART, delivered via an implantable pulse generator and lead system platform with proven reliability, has shown improvements in heart pump function, functional capacity, autonomic regulation of heart rate, and quality of life. ART may provide patients with meaningful improvement in their heart failure symptoms.
The VITARIA™ System is an extension of existing LivaNova VNS Therapy® platforms, which have a proven record of reliability over the past two decades. By electrically stimulating the vagus nerve, ART imparts cardioprotective benefits that act acutely and chronically to reduce the progression of cardiovascular disease.
Computer-controlled and battery powered, the Pulse Generator stimulates the vagus nerve in the neck through the electrodes of the VITARIA™ Lead, sending neurological signals to the heart, brain, and other neurological processors within the body.
The Lead is an insulated metallic conductor that is connected to the Pulse Generator on one end and connected to the vagus nerve via self-sizing helical cuffs on the other end. Electrical stimulation is applied through lead electrodes in the helical cuffs that are positioned on the surface of the vagus nerve. Electrode cuff stability is maintained by a helical cuff that acts as a passive tether to stabilize the lead position.
The VITARIA™ System is implanted using procedures that typically can be performed in less than one hour. The vagus nerve is isolated from the carotid sheath through a transverse cervical incision. The lead cuffs are attached and the lead body is stabilized. Following creation of a small ipsilateral subcutaneous infraclavicular pocket, a single-use surgical tool is used to aid in subcutaneous routing of the Lead from the neck incision to the chest incision. The two small incisions are closed after the lead has been attached to the Pulse Generator placed in the infraclavicular pocket.