FDA Approves First Wireless Implantable Pulmonary Artery Monitor
The FDA has approved the first permanently implantable wireless device with remote monitoring to measure pulmonary artery (PA) pressure in certain heart failure patients.
The target patients have New York Heart Association (NYHA) Class III heart failure and have been hospitalized for heart failure within the last year.
The CardioMEMS HF System can be used by patients at home or at a remote location and is designed to provide PA pressure measurements, including systolic, diastolic, and mean PA pressures. A physician can then review the data collected and make recommendations based on the patient’s medical status.
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The system contains a battery-free, permanently implanted sensor/monitory, a transvenous catheter designed to deploy the implantable sensor within the distal PA, and the CardioMEMS Hospital and Patient Electronics System to acquire and process signals from the sensor/monitor and transfer to the database.
In a clinical study, 550 participants with the implanted device were divided into a control or investigational group. The investigational group, where physician had access to PA pressure data, showed a clinically and statistically significant reduction in heart failure-related hospitalizations.
At 6 months, 98.6% of patients were free from device/system-related complications at 6 months and 100% of the devices were operational.
–Pooja Shah
Reference:
FDA. FDA approves first implantable wireless device with remote monitoring to measure pulmonary artery pressure in certain heart failure patients. 2014 May 28. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm399024.htm. Accessed June 2, 2014.