FDA approves first implantable heart monitor
- FDA has approved the first implantable heart monitor---a medical device co-developed by St. Jude Medical and CardioMEMs.
- It is a wireless system that tracks pulmonary artery pressure and transmits the information to healthcare providers.
- Thesystem is the only FDA-approved heart-monitoring technology that has been tested in large-scale clinical trials and demonstrated a significant reduction in hospitalizations due to heart failure.
The CardioMEMS system was developed to track heart function and reduce the risk of hospitalization due to heart failure. This wireless system is implanted directly into the pulmonary artery during a simple one-time procedure. By tracking pulmonary arterial pressure, the monitoring device can determine when there is increased risk of heart failure. In a large-scale clinical trial, using a pulmonary artery-based monitoring strategy decreased heart failure-related hospitalizations by 28% over a six-month period and by 37% over a 15-month period.