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First Intracranial Aneurysm Patients Treated with BRAVO Flow Diverter Following European Regulatory Approval
BRUSSELS, Belgium – September 19, 2018. CERENOVUS, part of the Johnson & Johnson Medical Devices Companies, announced today that the first patients have been treated with the BRAVO Flow Diverter, following recent CE mark approval for the device to be used in the treatment of intracranial aneurysms.
“The BRAVO Flow Diverter is a welcome addition to the existing treatment options for intracranial aneurysms” said Dr Patrick Brouwer Senior Consultant Neurointerventionalist at Karolinska University Hospital, and Evaluator for the BRAVO Flow Diverter. “I am impressed with the overall handling of the device, in particular the ease of use, opening functionality and stability of the device placement.”
Flow diverters divert blood flow from the aneurysm and promote healing thereby reducing the risk of rupture, a main cause of hemorrhagic stroke. Accurate positioning of the flow diverter and effective delivery and deployment are important factors in the successful treatment of intracranial aneurysms. The design of the BRAVO Flow Diverter reflects these requirements and aims to provide surgeons with confidence when positioning and deploying the device, contributing to complete diversion effect.
“We are delighted with the clinician feedback and patient outcomes from the early evaluation cases” said Daniella Cramp, Worldwide President, CERENOVUS. “After an extensive research and development process we are proud to see that our latest innovation is enabling patients to live a life free from the burden of hemorrhagic stroke.”
Stroke is a devastating disease that strikes 15 million people each year,1 with hemorrhagic strokes accounting for 13%2 of all strokes. Aneurysms are a main cause of hemorrhagic strokes and occur when a weakened region of a blood vessel balloons until it ruptures and bleeds into the brain.2
The device is currently not approved for use in the United States.
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, orthopaedics, cardiovascular and specialty solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.
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- The Economist Intelligence Unit (2016) Addressing the global stroke burden. [Online]. https://perspectives.eiu.com/sites/default/files/Addressingtheglobalstrokeburden_0.pdf. Last accessed May 2, 2018.
- American Stroke Association (2018) Hemorrhagic Strokes (Bleeds). [Online]. http://www.strokeassociation.org/STROKEORG/AboutStroke/TypesofStroke/HemorrhagicBleeds/Hemorrhagic-Strokes-Bleeds_UCM_310940_Article.jsp#.WypwpFVKjIW. Last accessed June 20, 2018.
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