Brain Aneurysm – A bulge or ballooning in a blood vessel in the brain that can leak or rupture, causing bleeding into the brain (aka hemorrhagic stroke). Aneurysms vary in size, shape & location. Complex wide-neck aneurysms are often "Irregular, non-saccular" in shape with a large opening (neck ≥ 4mm) of parent cerebral artery origin, much more difficult to treat, often requiring advanced interventional techniques/devices to ensure complete embolization and prone to high-risk of rupture.
3rd leading cause of death and disability with 15 million people worldwide have an unruptured aneurysm (6.5 million US). Approximately 30,000 ruptured aneurysms annually in the US (of that, ~85% are treatable). Ruptured aneurysms are fatal in 50% of cases, 66% of survivors suffer some permanent neurological deficit and/or death. Complex wide neck intracranial aneurysms account for ~38% of the total aneurysm population.
Intrasaccular devices (braided/woven), intrasaccular flow diverters/disruptors, flow-diverters, stents (stent-assisted coiling), hybrid coil-like devices, bare platinum coils, balloon/device-assisted coiling & surgical clipping (invasive) alternatives to treat various types of brain aneurysms.
Complex unruptured, ruptured irregular & acute angulated wide necked aneurysms present unique challenges to the operator. Current solutions to these complexities like flow diverters and stents require anticoagulants/blood thinner medication (DAPT - Dual Anti-Platelet Therapy) post-procedure. In some cases, DAPT may not be tolerated due to patient circumstances.
Many new devices involve increased technical complexity and steep learning curves. An unmet clinical need persists for an approach that maintains the familiar workflow of traditional embolic coiling without drastically changing the procedure.
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