MED.00115 Outpatient Cardiac Hemodynamic Monitoring Using a Wireless Sensor for Heart Failure Management Form

This document addresses the use of a wireless implantable hemodynamic system for ambulatory monitoring of heart failure, specifically the Cordella™ PA Pressure Sensor System (Endotronix, Inc., Lisle, IN) and the CardioMEMS^™ HF System (St. Jude Medical Inc., Atlanta, GA). These systems utilize a wireless pressure sensor that is permanently implanted via a right heart catheterization surgical procedure for the purpose of cardiac hemodynamic monitoring of individuals with heart failure in a non-clinical outpatient setting.

Note: For information regarding other technologies used for hemodynamic monitoring, see:

• SURG.00128 Implantable Left Atrial Hemodynamic Monitor

Position Statement

Investigational and Not Medically Necessary:

The implantation of a pressure sensor into the pulmonary artery for the purpose of wireless ambulatory monitoring of heart failure and all other indications is considered investigational and not medically necessary.