FDA Approves MR Conditional Tachycardia Devices from Biotronik

Biotronik announced Food and Drug Administration (FDA) approval of Iperia ProMRI HF-T, a cardiac resynchronization defibrillator that provides heart failure patients with access to diagnostic magnetic resonance imaging (MRI) scans. Iperia devices also have remote monitoring with daily automatic transmission and closed loop stimulation (CLS) that adapts the heart rate in response to physiological demands.

Iperia HF-T was developed with BIOTRONIK’s ProMRI, Home Monitoring, and CLS technology, creating an advanced cardiac resynchronization therapy defibrillator (CRT-D) designed to support each patient’s unique healthcare journey. BIOTRONIK’s MR conditional tachycardia devices ensure 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 percent. For heart failure patients, early detection of deterioration reduces patient mortality.

“The FDA approval of Iperia HF-T demonstrates the shift that is happening in cardiovascular patient care,” said Marlou Janssen, President, BIOTRONIK, Inc. “BIOTRONIK now offers a comprehensive portfolio of MR conditional ICDs. We’re driving the standard of care to new levels by providing physicians and hospitals with innovative, reliable, cardiac devices that ensure patients have access to imaging technology critical to diagnosing and treating future illness and injury. This is technology that is making a difference in patients’ lives.”

A press release can be found by following this link.