ZOLL® Medical Corporation, an Asahi Kasei Group company that manufactures medical devices and related software solutions, announced the launch of and first patient prescription for the ZOLL µCor™ (pronounced “Micro Core”) Heart Failure and Arrhythmia Management System (HFAMS), designed to help clinicians improve outcomes and reduce hospitalizations for heart failure patients with fluid management problems.
ZOLL HFAMS is an FDA-cleared patch-based, wireless system that employs novel radiofrequency technology to monitor pulmonary fluid levels, an early indicator for heart failure decompensation. The HFAMS sensor is non-invasive and can be worn by patients 24 hours a day. ZOLL HFAMS continuously records, stores, and transmits patient data, including Thoracic Fluid Index, heart rate, respiration rate, activity, posture, and heart rhythm (ECG).
Proprietary algorithms determine patient-specific trends in the data collected by HFAMS, allowing for early detection of deterioration in the patient’s condition. Certified technicians at ZOLL’s Medicare-approved and Joint Commission-accredited Independent Diagnostic Testing Facility monitor the data 24/7 and provide notifications according to pre-defined criteria. Data provided in the notifications aid the prescribing physician in the diagnosis and identification of various clinical conditions, events and/or trends, allowing for timely intervention.
The first patient has been prescribed the ZOLL HFAMS by Douglas Horstmanshof, MD, FACC, Co-Director of INTEGRIS Advanced Cardiac Care (IACC) and program director of the Heart Failure Institute (HFI) at INTEGRIS Baptist Medical Center (IBMC) in Oklahoma City.
“The ZOLL HFAMS is a promising addition to our toolbox to care for patients in our heart failure program, as it serves the goal of reducing the chances of readmission and can therefore improve patient care,” said Horstmanshof. “This device gives us insight through patient-specific data about thoracic fluid levels during a time when they are vulnerable to future heart failure events, allowing us to intervene prior to the onset of many symptoms related to decompensation.”
Every year in the U.S., more than 650,000 individuals are newly diagnosed with heart failure1 and the lifetime risk of developing this syndrome is one in five.2 Heart failure is one of the largest clinical challenges facing healthcare today, affecting nearly 6 million Americans and accounting for 1.2 million hospitalizations every year.3 The current U.S. expenditures for heart failure exceed $30 billion annually, with 60-80 percent related to hospitalization, and these figures are expected to grow in the future.4
“Despite improvements in medical therapy, 50 percent of patients hospitalized for heart failure are readmitted within six months of discharge, with the highest readmission rates occurring in the first 30 days,” said Jason T. Whiting, President of ZOLL Cardiac Management Solutions. “The ZOLL HFAMS’ remote monitoring of fluid level changes will help clinicians intervene in a timely manner by detecting early evidence of heart failure decompensation.”
ZOLL HFAMS is intended for use in outpatient clinic and home settings and is indicated for patients who are 21 years of age or older requiring fluid management.
1 Yancy CW et al. 2013 ACCF/AHA guideline for the management of heart failure, J Am Coll Cardiol. 2013;62:e147–239.
2Bui AL et al. Epidemiology and risk profile of heart failure, Nat Rev Cardiol. 2011 Jan;8(1): 30–41.
3Heidenreich PA et al. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association, Circ Heart Fail. 2013;6(3):606–619.
4Desai AS, Stevenson LW. Rehospitalization for heart failure: Predict or prevent? Circulation 2012;126(4):501-506.