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FDA Additionally Clears RAPID™ Imaging Platform for Use in Selecting Acute Stroke Patients for Clot Removal

January 15, 2019

MENLO PARK, Calif.--(BUSINESS WIRE)--Jan 15, 2019--iSchemaView, the worldwide leader in advanced imaging for stroke, today announced that the FDA has cleared the RAPID neuroimaging platform for use in selecting stroke patients who are likely to benefit from endovascular thrombectomy (clot removal). Specifically, this additional clearance means that RAPID CT-Perfusion and RAPID MR-Perfusion can be used by physicians to aid in the selection of acute stroke patients with known occlusion of the internal carotid artery or proximal middle cerebral artery for a clot removal procedure. RAPID is the only imaging platform approved for selecting stroke patients for clot removal.

“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,” said Don Listwin, CEO of iSchemaView. “The new clearance will particularly benefit smaller community hospitals and the patients they serve. 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.”

In addition to having the broadest FDA clearance of any cerebrovascular imaging software, RAPID is the only platform that is clinically validated in more than 10 major trials — including use for patient selection in landmark stroke studies such as SWIFT PRIME, EXTEND IA, and most recently, EXTEND. The RAPID platform was also the exclusive imaging system used for patient selection for two landmark stroke trials published in The New England Journal of Medicine, DAWN and DEFUSE 3, that successfully treated patients up to twenty-four hours after onset. The results of these studies changed the American Heart Association and American Stroke Association’s 2018 stroke guidelines to expand the stroke treatment window from six hours to 24 hours for eligible patients.

Developed by leading stroke experts, RAPID’s artificial intelligence framework combines unmatched expert feature extraction and proprietary algorithms to deliver the best-in-class platform, which includes tools for CT perfusion, MR diffusion and perfusion, CT angiography and CT ASPECT scoring. RAPID modules feature custom notifications, custom thresholding, hypoperfusion and cerebral blood volume indexes and golden hour thresholds.

About iSchemaView

iSchemaView is the world-wide leader in advanced imaging for stroke. Installed in over 1,000 stroke centers, iSchemaView’s RAPID (automated CTP, MR, CTA and ASPECTS), with enhanced AI framework, is the most advanced stroke imaging platform. In clinical trials, RAPID has been shown to aid in the selection of patients in early and late-window stroke trials, including SWIFT PRIME, EXTEND IA, DAWN, DEFUSE 3 and EXTEND. In addition to achieving the best clinical outcomes and largest treatment effects ever obtained, these landmark studies led to new American Heart Association and American Stroke Association guidelines and have dramatically altered the management of acute stroke around the world. For more information, visit www.iRAPID.com.

View source version on businesswire.com:https://www.businesswire.com/news/home/20190115005169/en/

CONTACT: Peter Evers

Natron Communications

(415) 524-8899

peter@natroncomm.com

KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA

INDUSTRY KEYWORD: TECHNOLOGY SOFTWARE HEALTH CARDIOLOGY MEDICAL DEVICES RADIOLOGY FDA

SOURCE: iSchemaView

Copyright Business Wire 2019.

PUB: 01/15/2019 09:00 AM/DISC: 01/15/2019 09:01 AM

http://www.businesswire.com/news/home/20190115005169/en

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