Dive Brief:
- 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.
Dive Insight:
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.