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% softer than the GALAXY G3™ XSFT 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.
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. According to the American Stroke Association, about 3 to 5 million people in the United States have cerebral aneurysms.
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. "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."