EBR Systems Issues Medical Device Correction with Updated Ultrasound Precautions for WiSE System Patients

Aakashdeep

12 November 2026 10:15 AM AEDT

EBR Systems Issues Medical Device Correction with Updated Ultrasound Precautions for WiSE System Patients

Image Source: Krish Capital Pty Ltd

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EBR Systems (ASX:EBR), developer of a wireless cardiac pacing device for heart failure, has announced a medical device correction for its WiSE® System, notifying healthcare professionals of updated safety precautions for diagnostic ultrasound imaging in patients implanted with the device.

Key Points

EBR has issued a medical device correction providing updated diagnostic ultrasound precautions for patients implanted with the WiSE® System.
Through 26 October 2026, EBR identified 17 reported events of ultrasound-induced inappropriate pacing among 586 implanted patients; one event resulted in death.
No device return, explant, or reprogramming is required as a result of the correction.
The company does not expect the forthcoming labelling update to have a material effect on its ongoing commercial activities or financial position.

Reported Events and Patient Population

Through 26 October 2026, EBR identified 17 reported events of ultrasound-induced inappropriate pacing among 586 implanted patients across global clinical, post-market, compassionate-use and commercial experience. One event resulted in death. According to the filing, these figures reflect reports received by EBR and do not represent the probability of an event during an individual transthoracic echocardiography (TTE) examination. The filing states that the estimated incidence rate per exam remains low, given the high volume of repeat ultrasound examinations that heart failure patients typically undergo as part of standard care.

Risk Factors and Clinician Guidance Issued

The filing identifies factors associated with increased risk of ultrasound-induced inappropriate pacing, including the first 30 days after electrode implantation, an apical or near-apical electrode location, high Mechanical Index settings, low-frequency ultrasound, and imaging from apical views. EBR stated that the absence of these factors does not eliminate the risk and that precautions apply to every TTE examination in patients with an implanted WiSE System. Healthcare professionals are directed to monitor patients continuously by ECG during echocardiography, keep external defibrillation equipment immediately available, use the lowest power setting providing a clinically adequate image, and immediately remove the probe if inappropriate pacing occurs.

Labelling Updates and Commercial Activity

EBR disclosed it is updating the Instructions for Use and Echo Protocol and will provide them through its electronic labelling resources once available. The company is requesting implanting centres share the communication with personnel involved in diagnostic ultrasound and review scheduling and handoff processes to ensure a patient's WiSE implant is identified before imaging. Commercial implants continue without interruption. EBR stated it does not expect the forthcoming labelling update to have a material effect on its ongoing commercial activities or financial position. EBR's senior management team planned to host an investor webinar on 12 November 2026 at 11:30am AEDT to discuss the announcement.

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