FDA Approves RAPID for Selecting Thrombectomy-Eligible Stroke Patients

The US Food and Drug Administration (FDA) has given an additional indication to the RAPID neuroimaging platform for the use of selecting stroke patients most likely to benefit from endovascular thrombectomy.

The approval, granted to advanced stroke imaging analysis company iSchemaView, makes RAPID the only imaging platform approved for optimizing clot removal in stroke patients in the US. RAPID computed tomography (CT)-Perfusion and RAPID magnetic resonance (MR)-Perfusion are now allowed for aiding physicians in selecting acute stroke patients with known occlusion of the internal carotid artery or proximal middle cerebral artery for endovascular thrombectomy.

According to iSchemaView, RAPID has the broadest FDA clearance among all cerebrovascular imaging software—having been clinically validated in 10-plus major trials as means of patients selection in landmark trials including:

• StentRetriever Thrombectomy after Intravenous t-PA vs t-PA Alone in Stroke (SWIFT PRIME)
• Endovascular Therapy for Ischemic Stroke with PerfusionImaging Selection (EXTEND IA)
• Extending the Time for Thrombolysis in Emergency Neurological Deficits (EXTEND)

The RAPID platform also served as the imaging system for patient selection in a pair of landmark stroke trials (DAWN; DEFUSE 3) which showed patients being successfully treated 24 hours following onset. The studies’ results helped influence the change of the American Heart Association and American Stroke Association’s 2018 stroke guidelines to extend treatment windows from 6 hours to 24 hours.

RAPID’s artificial intelligence framework includes tools for CT perfusion, CT angiography, Albert Stroke Program Early CT Score (ASPECTS), and MR diffusion.

Don Listwin, chief executive officer of iSchemaView, said the new FDA clearance will particularly aid smaller community hospitals and their patients—RAPID’s software enables quick, intuitive, real-time interpretations of brain perfusion. He noted that physicians will now be able to distinguish 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.”

“This FDA clearance confirms RAPID as the de facto standard in neuroimaging, not only for the automated analysis of brain images derived from CT and MRI, but now for the diagnosis and treatment of stroke,” Listwin said.