Abbott's CardioMEMS HF System Receives the US FDA’s Approval for the Treatment of Heart Failure
- The US FDA has approved an expanded indication for CardioMEMS HF System to support the patients care living with HF & for patients who undergo a blood test showed elevated levels of biomarkers that indicate worsening HF
- The approval was based on data on the (GUIDE-HF) trial in 3600 patients at 118 centers in North America which showed a 19% reduction in composite EPs of all-cause mortality & total heart failure events, 28% reduction in HF hospitalizations & improved care for patients with HF
- The CardioMEMS HF System is a small implantable sensor & a paperclip-sized device that placed in the pulmonary artery during an MIS, monitors for pressure changes indicating worsening HF
Ref: PR Newswire | Image: APK Pure
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