FDA Approves Novel Implanted Sensor to Monitor Heart Failure — Physician’s First Watch
FDA Approves Novel Implanted Sensor to Monitor Heart Failure
By Larry Husten
The FDA has approved the CardioMEMS HF System — a small implantable device that provides daily pulmonary artery (PA) pressure measurements to guide physicians in their treatment of patients who have been hospitalized with heart failure (New York Heart Association Class III) in the previous year.
The system consists of three parts: a small permanent sensor implanted in the pulmonary artery, a catheter-based delivery system, and a system that acquires and processes PA pressure measurements from the implanted monitor and transfers the data to a secure database.
In a news release, the FDA said that it "believes that there is reasonable assurance that the device is safe and effective for heart failure management with the goal of reducing the rate of heart failure–related hospitalizations in certain patients." The agency is requiring the company to conduct a postapproval study to examine how the device performs outside clinical trials.
Adapted from CardioExchange