Abiomed gains approval for data streaming from the Impella console

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Impella CP

The US Food and Drug Administration (FDA) has approved one-way digital data streaming during patient support from Abiomed’s Automated Impella Controller (AIC), the external console used with Impella heart pumps.

The data streaming capability is facilitated through the Impella Connect interface, a HIPAA-compliant, cloud-based remote monitoring platform that is currently installed at more than 200 hospitals. The approval means 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 an Abiomed press release.

As an example of how this technology might be used in future clinical practice, Abiomed has trained an AI algorithm to predict the next five minutes of a patient’s arterial pressure based on the prior five minutes of console data. Abiomed has also developed AI algorithms to predict other parameters, such as stroke volume, left ventricular pressure and cardiac output. The AI algorithms are not yet cleared or approved for patient use. Once fully developed, they will be submitted for regulatory review.

Predictive analytics are possible by integrating Impella clinical study data with Impella console data from thousands of cases and training AI networks on the co-registered data. AI networks could then receive and analyse console data in real-time and send patient-specific predictions to that patient’s medical provider.

“Artificial intelligence networks, properly trained using large volumes of streaming data, can be powerful tools to aid in clinical decision-making,” said Chuck Simonton, Abiomed’s chief medical officer. “One day, using artificial intelligence, physicians may be able to confidently predict a patient’s future haemodynamics. That would make clinical decision-making more efficient and improve patient outcomes.”


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