Abbott secures FDA approval for CardioMEMS HERO device 

The CardioMEMS HERO reader is part of Abbott’s CardioMEMS HF system.

Abbott has secured the US Food and Drug Administration (FDA) approval for its next-generation CardioMEMS HERO device, which is designed to support remote heart failure monitoring.

The new pulmonary artery (PA) pressure reader aims to provide patients and clinicians with daily data to help detect and address the progression of heart failure.

It is part of Abbott’s CardioMEMS HF system and features a design similar in size to a laptop case, and is smaller and lighter than previous models.

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The device works in conjunction with the implanted CardioMEMS PA sensor, which monitors changes in PA pressure, an important indicator of worsening heart failure.

Patients use the HERO reader by lying on it for under 60 seconds to transmit a remote PA pressure reading securely to their care team. Based on these daily readings, clinicians can adjust medications or recommend lifestyle changes to help manage heart failure progression, often before symptoms become evident.

The reader offers several updated features, including being 60% lighter than its predecessor, making it portable enough for daily use and travel.

The improved design helps maintain a consistent patient position during readings, ensuring reliable daily PA pressure trends.

Integrated Wi-Fi and cellular capabilities enable patients to take readings anywhere a signal is available.

The HERO reader remains compatible with existing CardioMEMS PA Sensors available commercially.

Abbott heart failure business chief medical officer and divisional vice-president Finn Gustafsson said: “Abbott’s CardioMEMS HERO reader is modernising a proven and effective remote patient management system, making it even more convenient for patients to use a device that has shown a 57% reduction in heart failure hospitalisations.

“With this new reader, people can work with their doctors to proactively manage their condition outside of the doctor’s office even more efficiently – increasing convenience and the patient experience.”

Prior to this, Abbott commenced a trial of its Volt pulsed-field ablation (PFA) system for atrial fibrillation (AFib) treatment at 15 National Health Service (NHS) hospitals in the UK, demonstrating the system’s capability to perform ablation procedures with patients under conscious sedation instead of general anaesthesia.

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