News | Heart Failure | June 07, 2016

CardioMEMS HF System Added to European Guidelines for Heart Failure Patients

Designation allows expanded access for appropriately identified heart failure patients, backed by CHAMPION trial data

CardioMEMS HF, heart failure patients, European Society of Cardiology guidelines

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

Related Content

Heart Failure Market to Surpass $16 Billion by 2026
News | Heart Failure| September 19, 2017
The heart failure space across the seven key markets of the U.S., France, Germany, Italy, Spain, the U.K. and Japan is...
Heart Failure Patients, Clinicians Have Differing Perceptions of Risk Level
News | Heart Failure| September 06, 2017
September 6, 2017 — Physicians identified a majority of patients with advanced...
Israeli Hospital Completes First Implant of CORolla Heart Failure Device
News | Heart Failure| September 05, 2017
Rambam Hospital in Haifa, Israel, recently became the first to use the CORolla device from Israeli start-up company...
Abbott Receives FDA Approval for HeartMate 3 Left Ventricular Assist System
Technology | Ventricular Assist Devices (VAD)| August 29, 2017
Abbott announced it has received U.S. Food and Drug Administration (FDA) approval for its Full MagLev HeartMate 3 Left...
Sponsored Content | Videos | Cardiovascular Ultrasound| August 28, 2017
This video educational session, provided in partnership with the American Society of Echocardiography (ASE), is title
Biotronik Announces U.S. Launch of Edora HF-T QP CRT Pacemaker
Technology | Cardiac Resynchronization Therapy Devices (CRT)| August 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and commercial availability of Edora HF-T QP, an...
Registry Identifies Early Onset of Heart Failure and Lack of Defibrillators in Asia
News | Heart Failure| August 03, 2017
August 3, 2017 — The Asian Pacific Society of Cardiology (ASPC) held its first-ever late-breaking...
Left Atrial Pressure Monitor from Vectorious Medical Technologies Offers New Hope for Heart Failure Patients

On of the top stories in July was the introduction of a left atrial pressure monitor from Vectorious Medical Technologies to prevent heart failure patient hospitalizations or readmissions. Read the article"Left Atrial Pressure Monitor Offers New Hope for Heart Failure Patients."

Feature | August 01, 2017 | Dave Fornell
Aug.
Wearable monitors create patient generated health data, PGHD, that can help prevent acute care episodes in heart failure.

Wearable monitoring devices may offer a new tool to help prevent acute care episodes in heart failure.

Feature | Heart Failure| July 25, 2017 | Lola Koktysh
Despite their best efforts, many patients tend to develop heart failure after an acute event (e.g., a heart attack or
Overlay Init