FDA approves Iperia MR conditional cardiac resynchronisation defibrillators



The Iperia ProMRI HF-T (Biotronik), a cardiac resynchronisation defibrillator designed to provide heart failure patients with access to diagnostic magnetic resonance imaging (MRI) scans, has been approved by the US Food and Drug Administration (FDA).

Iperia devices also use remote monitoring with daily automatic transmission and closed loop stimulation (CLS) that is intended to adapt the heart rate in response to physiological demands.

Theofanie Mela, an electrophysiologist at Massachusetts General Hospital (Boston, USA) who participated in the testing of this device, says “Access to MRI scans is a critical step to ensuring quality patient care extends beyond device implantation. This must become the standard of care.”

Iperia HF-T was developed with Biotronik’s ProMRI, Home Monitoring, and CLS technology, creating a cardiac resynchronisation therapy defibrillator (CRT-D) designed to support each patient’s particular healthcare needs. Biotronik’s MR conditional tachycardia devices should ensure that patients have access to 1.5T scans without an exclusion zone. Home Monitoring provides automatic daily transmission of data relating to arrhythmic events and heart failure statistics, which have been shown to reduce all-cause mortality by more than 50%. For heart failure patients, early detection of deterioration reduces patient mortality.