IRVINE, CA – Jan. 24, 2018 – CERENOVUS, part of the Johnson & Johnson Medical Devices Companies, today announced the launch of the GALAXY G3 MINI Coil, its smallest and softest embolic finishing coil, for use in the endovascular treatment of cerebral aneurysms and hemorrhagic stroke. The company received 510 (k) clearance for the device from the U.S. Food and Drug Administration (FDA) in late September 2017.
GALAXY G3 MINI Coils are about 25 percent softer than the GALAXY G3 XSFT[1] Coils, the company’s other finishing coil and have an ultra-low coil profile with a primary wind diameter of 0.009-inches, the lowest available in the CERENOVUS SPECTRA Family of Coils.
The new coil is the latest addition to the GALAXY G3 Microcoil portfolio of filling and finishing coils which all feature stretch resistance technology and a proprietary complex random loop design. The GALAXY G3 MINI Coil is designed to have a random complex shape which may make the coil conformable and enable them to seek and fill open spaces in cerebral aneurysms to achieve higher packing densities, which have been shown to lower patient retreatment rates.[2][3][4][5]
Brain aneurysms are weak spots on blood vessels that have the potential to rupture and cause bleeding within the brain. They can lead to serious complications, including hemorrhagic stroke, permanent nerve damage or death.[6] According to the American Stroke Association, about 3 to 5 million people in the United States have cerebral aneurysms.[7]
During a minimally invasive coiling procedure, tiny coils are inserted directly into the aneurysm to induce clotting or embolization and prevent rupture. The coils may be of various shapes, sizes and configurations and are deployed by the physician based on the anatomy and shape of the aneurysm.
“Now, CERENOVUS brings a family of endovascular coils that offers physicians a total procedural solution that can be used from start to finish or from periphery to core,” said Shlomi Nachman, Company Group Chairman of Johnson & Johnson Medical Devices Cardiovascular & Specialty Solutions. “We will continue to work to advance the treatment of cerebral aneurysm and both hemorrhagic and ischemic stroke to help physicians give stroke patients a new lease on life.”
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. Visit www.cerenovus.com for more information.
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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[1] Test Report Number 103421831; report data on file with CERENOVUS
[2] Slob MJ, et al. “Influence of coil thickness on packing, re-opening and retreatment of intracranial aneurysms: a comparative study between two types of coils.” Neurological Research 2005;27(1).
[3] Hirsch J, et al. “Midterm clinical experience with a complex-shaped detachable platinum coil system for the treatment of cerebral aneurysms: TRUFILL DCS ORBIT detachable coil system.” Journal of Vascular and Interventional Radiology 2007;18:1487-94.
[4] Wakhloo A, et al. “Complex-shaped platinum coils for brain aneurysms: higher packing density, improved biomechanical stability and midterm angiographic outcome.” American Journal of Neuroradiology2007;28:1395-40.
[5] Van Rooij WJ, et al, Packing performance of GDC 360˚ coils in intracranial aneurysms: a comparison with complex ORBIT coils and helical GDC 10 coils. AJNR 2007;28.
[6] https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Cerebral-Aneurysms-Fact-Sheet
[7] http://www.strokeassociation.org/STROKEORG/AboutStroke/TypesofStroke/HemorrhagicBleeds/What-You-Should-Know-About-Cerebral-Aneurysms_UCM_310103_Article.jsp
