Zoll Launches FDA-Cleared Remote-Monitoring System for Heart Failure

Zoll Medical Corporation today launched its µCor Heart Failure and Arrhythmia Management System, a remote-monitoring tool designed to reduce hospitalizations and improve outcomes for heart failure patients with fluid management problems.

The device is a U.S. Food and Drug Administration (FDA)-cleared patch-based wireless system that employs radiofrequency technology to monitor pulmonary fluid levels, which is an early sign of heart failure decompensation. The FDA gave the device a premarket notification in May 2018. Bram Zuckerman, M.D., director of the division of cardiovascular devices, wrote the device is substantially equivalent to legally marketed predicate devices and thus can be marketed.

The patch can be worn by patients all day. It records, stores and transmits patient data, including thoracic fluid content, heart and respiration rate, activity, posture and heart rhythm.

Recorded data give physicians insights into patient-specific trends that can help for early detection of deterioration in the patient’s condition. Physicians can use the data to aid diagnosis and identification of clinical conditions.

“This device gives us insight through patient-specific data about thoracic fluid levels during a time when they are vulnerable to heart failure events, allowing us to intervene prior to the onset of many symptoms related to decompensation,” said Douglas Horstmanshof, M.D., co-director of Integris Advanced Cardiac Care.

Heart failure affects nearly 6 million Americans and accounts for 1.2 million hospitalizations each year. Half of the patients hospitalized for the condition are readmitted within six months. Remote-monitoring systems have the potential to serve as a useful tool for physicians and patients to stay on top of the disease.

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