June 7, 2016 — St. Jude Medical Inc. announced that its CardioMEMS HF System was added to the European Society of Cardiology (ESC) guidelines as a directed therapy management and monitoring tool for heart failure patients. The new 2016 ESC Clinical Practice Guidelines for the diagnosis and treatment of acute and chronic heart failure for the first time include pulmonary artery pressure monitoring with the CardioMEMS HF System.
Robust clinical data from the CHAMPION study was used to establish this Class IIb recommendation for the CardioMEMS HF System within the guideline directed therapy for heart failure patients.
“The ESC guideline for the CardioMEMS HF System provides direction for physicians who are working to appropriately treat our heart failure patients and reduce their risk of repeated heart failure hospitalizations,” said Giovanni Battista Perego, M.D., from Istituto Auxologico Italiano, Milan, Italy.
The data supporting this decision include evidence based on the CHAMPION study and applies to all Class III heart failure patients regardless of their ejection fraction (measurement of how much blood is pumped out of the heart).
According to St. Jude Medical, the CardioMEMS HF System is the first and only CE Mark-approved heart failure monitor that, when used by physicians, has been shown to significantly reduce heart failure hospital admissions and improve the quality of life in New York Heart Association (NYHA) Class III patients.
Long-term, prospective data published in The Lancet supports the effectiveness of the CardioMEMS HF System at reducing heart failure hospitalizations by demonstrating the system can provide physicians with the hemodynamic data to proactively manage their heart failure patients.
The CHAMPION trial originally demonstrated a statistically and clinically significant 28 percent reduction in the rate of HF hospitalizations at six months, and a 37 percent reduction in HF hospitalizations during an average follow-up duration of 15 months.
In addition, recently published data in Circulation: Heart Failure showed that management with the CardioMEMS HF System significantly reduced 30-day hospital readmission rates for Medicare-eligible patients.
Approximately 23 million people worldwide are afflicted with congestive heart failure and 2 million new cases are diagnosed worldwide each year.
For more information: www.escardio.org