by
Lauren Dubinsky, Senior Reporter | May 05, 2016
Biotronik's Iperia ProMRI HF-T
Biotronik announced Tuesday that its Iperia ProMRI HF-T cardiac resynchronization defibrillator has received FDA approval. It’s among a number of other recently-approved products that enable heart failure patients to undergo MR exams.
"Care is an ongoing process that spans a patient's unique journey to well-being,” Marlou Janssen, president of BIOTRONIK, told HCB News. “Unfortunately, patients with heart disease often suffer from other illnesses so we must always think about what lies ahead in the patient's care journey.”
About 5.1 million people in the U.S. have heart failure, according to the Centers for Disease Control and Prevention. Those individuals are often dealing with other health conditions that require medical intervention at the same time, so access to MR is imperative.
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In February, Medtronic received FDA approval for the first MR-compatible cardiac resynchronization therapy defibrillator (CRT-D) for treating heart failure. CRT-Ds are pacemakers that deliver defibrillator therapy.
Among the patients with defibrillators and CRT-Ds, about 40 percent will require an MR exam within the first four years of having the device implanted. In the May issue of DOTmed HCB News magazine, we explore MR-compatible CRT-Ds in depth.
The Iperia HF-T includes Biotronik’s Home Monitoring technology — which automatically transmits data on the patient's arrhythmic events and heart failure statistics on a daily basis, and has been shown to reduce all causes of mortality by more than 50 percent.
Atrial or ventricular arrhythmia or specific trends in certain clinical parameters can be the first sign of worsening heart failure, which could lead to hospitalization or death. If physicians are able to detect those events early, especially asymptomatic atrial fibrillation, they are able to adapt patient therapy at a very early stage.
The CLS technology adapts the heart rate in response to physiological demands. It adapts the heart rate even when the person’s heart is racing, but their body is still, for example, if they find out that their flight is canceled and that they will miss a meeting.
