Release date: 2014-06-04
On May 28, 2014, the US Food and Drug Administration (FDA) approved the first wireless, implantable hemodynamic monitoring system for patients with heart failure, CardioMEMS, which considers the system's effectiveness and safety. It has reasonable assurance that it can be used for the management of patients with target heart failure and reduce the hospitalization rate associated with heart failure.
The CardioMEMS (Champion HF Monitoring System) measures the patient's mean pulmonary arterial pressure and heart rate and is approved for use in NYHA Level 3 patients with a history of heart failure hospitalization in the past year.
The FDA approved the system primarily based on the CHAMPION study, an open label study. The study showed that in patients with NYHA class 3 heart failure with dyspnea, the pulmonary artery pressure sensor group was reduced by 30% compared with the standard treatment group.
In 2013, the FDA advisory team approved the approval of the permanently implanted diagnostic device with a 6:4 weak voting advantage and considered it to have a better risk-to-benefit ratio. But in 2011, the FDA advisory group voted against the approval of the device.
Source: Medical Pulse
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