LAKE OSWEGO, OR —The US Food and Drug Administration today approved the smallest magnetic resonance (MR)-conditional quadripolar cardiac resynchronization pacemaker available in the United States, according to a news release from the device maker, Biotronik.
The Edora HF-T QP has a volume of 15 cc and a battery life of nearly 10 years, which the company says reduces the frequency of device replacement for patients with heart failure.
The new pacemaker features MRI AutoDetect, which allows the pacemaker to be programmed to automatically switch to MRI mode when patients enter the MR imaging environment.
It also includes closed loop stimulation and Biotronik Home Monitoring, which provides automatic daily updates and a summary of nine long-term heart failure (HF) statistics including thoracic impedance, the report states.
Biotronik reports that their device is the only cardiac device monitoring system proven to improve health outcomes in heart failure, with recent studies showing it was associated with more than a 50% reduction in HF mortality and a 36% reduction in hospitalizations for worsening HF.
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