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July 16, 2020

FDA Approves Data Streaming From Abiomed’s Impella Console

July 16, 2020—Abiomed announced FDA approval of one-way digital data streaming during patient support from the company’s automated Impella controller, the external console used with Impella heart pumps. The data-streaming capability is facilitated through Abiomed’s Impella Connect interface, a HIPAA-compliant, cloud-based remote-monitoring platform that is currently installed at more than 200 hospitals.

With the approval, console data could be streamed live via Impella Connect to a secure server where artificial intelligence (AI) could provide predictive clinical information to the patient’s physician.

According to the company, examples of how this technology might be used in future clinical practice include the following:

  • Abiomed has trained an AI algorithm to predict the next 5 minutes of a patient’s arterial pressure based only on the previous 5 minutes of console data.
  • Abiomed has developed AI algorithms to predict parameters such as stroke volume, left ventricular pressure, and cardiac output.

The AI algorithms are not yet cleared or approved for patient use. When fully developed, they will be submitted for regulatory review, noted Abiomed.

The company explained that predictive analytics are possible by integrating Impella clinical study data with Impella console data from thousands of cases and training AI networks on the coregistered data. AI networks could then receive and analyze console data in real time and send patient-specific predictions to that patient’s medical provider.

Abiomed is also studying AI to make more holistic predictions, such as the probability a patient will recover his or her native heart function. This information could help medical providers determine if an alternative course of action is needed, stated the company.

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