Biotronik Iperia ProMRI HF-T Defibrillator Approved

FDA has approved a Biotronik PMA for its Iperia ProMRI HF-T, a cardiac resynchronization defibrillator that provides heart failure patients with access to diagnostic magnetic resonance imaging scans. The device also has a remote monitoring feature with daily automatic transmission, and a closed-loop stimulation feature that adapts the heart rate in response to physiological demands, according to the company.

Biotronik says its home monitoring accessory can be programmed by a physician to transmit data automatically, “thereby rapidly detecting deterioration in a patient's clinical status. The occurrence of atrial or ventricular arrhythmias or specific trends in certain clinical parameters can often be the first sign of worsening heart failure leading to hospitalization or death. Early detection of these clinically relevant events, in particular asymptomatic atrial fibrillation, enables the physician to adapt patient therapy at a very early stage.”