FDA Approves CardioMEMS Wireless HF Monitor
May 28th, 2014
The FDA announced that is has granted approval for the first wireless cardiac monitor that measures heart rates & pulmonary artery pressure for patients diagnosed with Heart Failure. The CardioMEMS device is revolutionary as it can assist clinicians in remotely monitoring patients that have been admitted to the hospital for heart failure within the last year. This represents a significant technological stride as it has the potential to enhance monitoring capabilities and lower the astronomical costs associated with hospitalizations for heart failure.
The CardioMEMS HF System is used by the patient in the home or other remote location. This is the first permanently implantable wireless system intended to provide PA pressure measurements, including systolic, diastolic and mean PA pressures. The PA pressure data are reviewed by physicians who can make decisions regarding the status of the patient and, if necessary, initiate changes in medical therapy, with the goal of reducing hospitalization due to heart failure.
Heart Failure is a serious medical condition where the heart is mechanically incapable of delivery adequate blood supply to the body. Heart Failure affects nearly 6 million people each year affecting long term survival. Heart Failure often results in symptoms of shortness of breath and often prohibits patients from living an active lifestyle. Further, Heart Failure is said to be the most common (and expensive) source for hospitalizations for cardiac patients over the age of 65.
The CardioMEMS HF device is said to be clinically viable as it enables physicians to remotely monitor the patient’s pulmonary artery pressure. A study was published that documents a significant reduction in heart failure-related hospitalizations (for patients) due to improved management when physicians can remotely access pulmonary artery pressure data.