CERENOVUS Announces First Patient Enrolled in MEMBRANE Study on Chronic Subdural Hematomas
MEMBRANE study will evaluate TruFill® n-BCA Liquid Embolic System in the embolization of middle meningeal artery as a treatment of chronic subdural hematoma
IRVINE, CA – June 9, 2021 – Johnson & Johnson Medical Devices Companies* today announced the first patient was enrolled in the CERENOVUS-sponsored MEMBRANE study evaluating TruFill® n-BCA Liquid Embolic System in the embolization of middle meningeal artery (MMA) for treatment of chronic subdural hematoma (cSDH) as adjunct to surgical evacuation or as a stand-alone treatment. The randomized study is designed to evaluate the safety and effectiveness of TruFill® n-BCA for the treatment of cSDH, which is still in the investigational stages, and is an important step in the U.S. Food and Drug Administration’s (FDA’s) approval process.
Chronic subdural hematoma (cSDH) is a common neurological disease caused by the accumulation of blood clots on the surface of the brain beneath its outer covering and occurs frequently in older patients who have brain atrophy. As brain tissue shrinks or wastes away, minor head injuries can cause small tearing of blood vessels over the brain surface, leading to blood slowly accumulating over several days or weeks.1 Current trends predict that by 2030, more than 60,000 new cases of cSDH will occur in the United States each year, which will make cSDH the most common neurosurgical condition in adults.2
“As more people in the United States are diagnosed with cSDH, it is critical to explore and understand the potential of MMA embolization to treat this condition safely and effectively,” said Mark Dickinson, Worldwide President, CERENOVUS. “CERENOVUS is committed to developing differentiated solutions to meet physicians’ needs, so they can best support patient populations who face the burden of neurovascular disease.”
The MEMBRANE study will enroll over 300 participants in 35 sites across the United States over the next two years. Participants in the study will be followed for a one-year period. The first patient was enrolled at WVU Rockefeller Neuroscience Institute by Ansaar Rai, M.D. The primary investigators of the study are Dr. Rai, Professor and Chair of Neuroradiology at Rockefeller Neuroscience Institute, West Virginia University School of Medicine in Morgantown, West Virginia and Christopher Kellner, M.D., Assistant Professor in Neurosurgery and Director of the Intracerebral Hemorrhage Program at Mount Sinai Health System, New York.
“The first patient enrollment in the MEMBRANE trial is an exciting milestone for our teams in evaluating MMA embolization as a treatment option for cSDH,” said Dr. Kellner. “We are looking forward to exploring the potential of providing physicians additional ways to address and manage this disease, especially in older adults, who may be more at risk to undergo surgery,” said Dr. Rai.**
About CERENOVUS
CERENOVUS, part of 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. For more information, visit www.cerenovus.com and connect on LinkedIn and Twitter.
About Johnson & Johnson Medical Devices Companies
As the world’s most comprehensive medical devices business, we are building on a century of experience, merging science and technology, to shape the future of health and benefit even more people around the world. With our unparalleled breadth, depth and reach across surgery, orthopedics, vision and interventional solutions, we’re working to profoundly change the way care is delivered. We are in this for life. For more information, visit www.jnjmedicaldevices.com.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the EXCELLENT Registry. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of CERENOVUS, any of the other Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither CERENOVUS, any of the other Johnson & Johnson Medical Devices Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
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* The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, vision and interventional solutions businesses. CERENOVUS is part of the Johnson & Johnson Medical Devices Companies.
** Ansaar Rai, M.D. is a paid consultant to CERENOVUS.
- Chronic subdural hematoma. UCLA Health. Accessed April 16, 2021.
- Balser D, Farooq S, Mehmood T, et al. Actual and projected incidence rates for chronic subdural hematomas in United States Veterans Administration and civilian populations. J Neurosurg 2015;123:1209–15.
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