ESC Guidelines Include St. Jude Medical’s CardioMEMS HF System for Heart Failure Patients
June 6, 2016—St. Jude Medical, Inc. announced that its CardioMEMS HF heart failure monitor system was added to the European Society of Cardiology (ESC) guidelines as a directed therapy management and monitoring tool for heart failure patients. For the first time, the new 2016 ESC Clinical Practice Guidelines for the diagnosis and treatment of acute and chronic heart failure include pulmonary artery pressure monitoring with the CardioMEMS HF system. The guidelines are available online in the European Heart Journal.
According to the company, clinical data from the CHAMPION study were used to establish this class IIb recommendation for the CardioMEMS HF system within the guideline-directed therapy for heart failure patients. The data apply to all class III heart failure patients regardless of their ejection fraction. The CardioMEMS HF system, which has received European CE Mark approval, has been shown to significantly reduce heart failure hospital admissions and improve the quality of life in New York Heart Association class III patients.
In the company’s announcement, Giovanni Battista Perego, MD, commented, “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.” Dr. Perego is from Istituto Auxologico Italiano in Milan, Italy.
The CHAMPION trial originally demonstrated a statistically and clinically significant 28% reduction in the rate of heart failure hospitalizations at 6 months, and a 37% reduction in heart failure hospitalizations during an average follow-up duration of 15 months. The CardioMEMS HF system is a proven treatment for New York Heart Association class III heart failure patients who have a preserved ejection fraction, which makes up approximately half of all heart failure patients.
In November 2015, St. Jude Medical, Inc. announced the publication of prospective data in The Lancet by Prof. William T. Abraham, MD, et al that further support the long-term effectiveness of the company’s CardioMEMS HF system at reducing heart failure hospitalizations for patients with New York Heart Association class III heart failure (2016;38:453–461). In 2011, CardioMEMS announced the first publication of the CHAMPIONS data by Dr. Abraham et al in The Lancet (2011;377:658–666). In addition, data recently published by Philip B. Adamson, MD, et al online ahead print in Circulation: Heart Failure showed that management with the CardioMEMS HF system significantly reduced 30-day hospital readmission rates for Medicare-eligible patients. The CardioMEMS HF system received US Food and Drug Administration approval in 2014.