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Abbott Wins FDA Approval for CardioMEMS HERO Reader

The CardioMEMS HERO reader is similar in size to a laptop case and smaller than the system’s previous model.

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By: Sam Brusco

Associate Editor

Abbott announced that the U.S. Food and Drug Administration (FDA) approved its CardioMEMS HERO device, a next-generation pulmonary artery (PA) pressure reader to support heart failure care.

The CardioMEMS HERO reader is a new component of the CardioMEMS HF system. It’s similar in size to a laptop case and smaller than the system’s previous model. It works with the CardioMEMS PA sensor, a paperclip-sized device implanted near the heart where rising PA pressures indicate worsening heart failure.

To take a remote PA pressure reading, patients lay on their back centered on the HERO reader for 60 seconds on average. The data is then securely sent to their care team. Clinicians will receive daily data readings and if they observe PA pressure changes, they’ll communicate any medication of lifestyle changes needed to help slow heart failure progression. This is often before a patient feels symptoms, in an effort to keep them out of the hospital.

Since the HERO reader is 60% lighter than the previous model, the smaller size makes it easier to use every day, Abbott said. It’s also designed to fit in a carry-on suitcase to make travel more convenient, and its improved design allows a consistent reading position to provide reliable daily pressure trends.

HERO is also the only patient reader with integrated Wi-Fi and cellular connectivity so patients can take a reading virtually anywhere that they have a signal.

“Data from CardioMEMS HF System clinical trials show the positive impact the device has on reducing the risk of heart failure hospitalizations and cardiovascular death. HERO is likely to significantly enhance data acquisition and patient interactions with this life-changing technology,” said JoAnn Lindenfeld, M.D., director of advanced heart failure at Vanderbilt University Medical Center in Nashville, Tenn, who served as primary investigator for the GUIDE-HF study—the largest randomized clinical trial conducted on pulmonary artery pressure monitoring. “HERO is lighter, more comfortable, and easier to transport and use which improves patient experience.”

Last month, Abbott announced positive early results from the VERITAS study, which showed clinically meaningful closure rates of its investigational Amulet 360 left atrial appendage (LAA) occluder.

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