LAKE OSWEGO, Oregon, May 3, 2016 – BIOTRONIK, a leader in cardio- and endovascular medical technology, today 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.More than five million Americans suffer from heart failure (HF). The condition occurs when the heart isn’t able to pump enough blood and oxygen to the rest of the body. Patients, often elderly and living with significantly diminished quality of life, are at high risk for comorbidities, including diabetes, cardiac arrhythmias, depression, and falls that can lead to hospitalization.“Heart failure patients are often struggling with other health conditions that require medical intervention,” said Dr. Theofanie Mela, an electrophysiologist at Massachusetts General Hospital who participated in the testing of this device. “These patients need effective and efficient treatment. 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 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 mortality1
.“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.”
- Hindricks G et al. Lancet. 2014, 384 (9943).
- Investigational Device: Limited by US law to investigational use.