FDA Approves Use of Imaging Platform to Select Patients for Clot Removal

Friday, January 18, 2019

The Food and Drug Administration (FDA) has approved a neuroimaging platform (RAPID; iSchemaView, Menlo Park, CA) for selecting stroke patients who are likely to benefit from endovascular thrombectomy. 

Physicians can use the platform to select acute stroke patients with known occlusion of the internal carotid artery or proximal middle cerebral artery to receive a clot removal procedure. The platform includes tools for CT perfusion, MR diffusion and perfusion, CT angiography, and CT aspect scoring.

The platform has been validated in more than 10 clinical trials, including SWIFT PRIMEEXTEND IADAWNDEFUSE 3, and EXTEND. The results of these studies led the American Heart Association (AHA) and American Stroke Association (ASA) to change their 2018 stroke guidelines, expanding the stroke treatment window from 6 hours to 24 hours for eligible patients.

“Because RAPID enables stroke treatment decisions that are based on intuitive and easily interpretable real-time views of brain perfusion, physicians will quickly and easily be able to determine which patients can be treated locally and which require urgent transfer to thrombectomy centers—bolstering the capabilities of smaller hospitals and therefore improving patient care.” said Don Listwin, CEO of iSchemaView.

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