ARISE II Clinical Trial Results Presented at International Stroke Conference
LOS ANGELES – Jan. 25, 2018 – EMBOTRAP® Device, a device designed to remove clots from the brain following an ischemic stroke, demonstrated high success rates in restoring blood flow and patients achieved high rates of functional independence, according to ARISE II (Analysis of Revascularization in Ischemic Stroke with EMBOTRAP® Device), a new clinical trial presented today at the American Stroke Association’s (ASA) International Stroke Conference 2018.[2]
Strokes strike nearly 800,000 Americans each year, and are a leading cause of disability, and the fifth leading cause of death.[1] For stroke patients, the difference between life and death, and functional independence or disability, is tied to timely restoration of blood flow to the oxygen-starved brain after a stroke event occurs. In the U.S. alone, the economic burden of stroke is estimated at $34 billion annually, which includes the cost of health care services, medications, and lost productivity.
In the ARISE II study, neurointerventional stroke physicians were able to restore blood flow in 80 percent of patients treated with EMBOTRAP® Device within three passes (with a reperfusion grade of mTICI ≥2b). By the end of the procedure, vessels were opened in 93 percent of patients. In addition, substantial reperfusion (mTICI 2c or 3) was achieved with just a single pass in half the patients. At the 90-day follow-up, 67 percent were functionally independent. Overall, the study successfully met the prespecified endpoints.
“I believe the EmboTrap device will be an important new option for treating stroke patients,” said Osama Zaidat, MD, Stroke and Neuroscience Medical Director of St. Vincent Mercy Hospital, who presented the findings at the conference. “The study results look strong with very encouraging outcomes achieved for reperfusion, modified Rankin Scale, speed to revascularization as well as the rate of first pass success.”
ARISE II was a multicenter clinical study of 228 patients, conducted to assess the safety and effectiveness of the EMBOTRAP® Device, a next-generation stent retriever designed to retrieve a broad range of clot types. Patients eligible for the study had large vessel occlusions (LVO) and moderate to severe neurological deficits within eight hours of symptom onset.
“We were honored to work with an eminent team of international physicians committed to advancing stroke therapy,” said Mairsíl Claffey, Head of Clinical and Regulatory, Ischemic stroke for CERENOVUS. “We are pleased that both the ARISE II results, and the physician feedback during the study reflect positively on the EMBOTRAP® Device design and the extensive clot research which forms its foundation. This research underpins our commitment to developing evidence-based stroke solutions to enhance patient care.”
The EMBOTRAP® Device platform was developed by Neuravi Limited. CERENOVUS acquired Neuravi Limited in April 2017. CERENOVUS has submitted the ARISE II study data as part of its application to the U.S. Food and Drug Administration (FDA) for marketing clearance of EMBOTRAP® Device in the United States. The device is already approved for use in Europe, where more than 3,000 patients have been treated.
About CERENOVUS
CERENOVUS, part of the Johnson & Johnson Medical Devices Companies, is a global leader in neurovascular care. Our commitment to changing the trajectory of stroke is inspired by our long heritage and dedication to helping physicians protect people from a lifetime of hardship. CERENOVUS offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke.
About the Johnson & Johnson Medical Devices Companies
The Johnson & Johnson Medical Devices Companies’ purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopedics, cardiovascular and specialty solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.
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[1] http://www.strokeassociation.org/STROKEORG/AboutStroke/Impact-of-Stroke-Stroke-statistics_UCM_310728_Article.jsp#.WmDsuSOZMQ8
[2] https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_stroke.htm
