Introduction Intracranial aneurysm rupture claim 15,000 American lives per year and impair over 9000 with neurological deficits. Current treatments are unable to remove the aneurysm threat permanently. Even after an endovascular treatment, an aneurysm could still regrow (recanalize) and rupture. Approximately 25% of patients receiving medical treatment will still die from an aneurysm rupture. Endovascular treatments can benefit from a novel medical device that seals along the aneurysm neck during device delivery to the aneurysm sac while allowing blood flow to perfuse the parent artery, thereby reducing the occurrence of complications resulting from endovascular device placement.
Methods The stent-balloon device is composed of a ultra-high compliant urethane balloon that extends over a self-expandable, shape-memory Nitinol braided stent/mesh (100–500 um average pore size) attached to a 0.010–0.018’ micro-guidewire/retriever (figure 1-a). The stent/mesh (similar dimensions to an LVIS Jr®) is delivered through the large (~0.018’ ID) primary lumen and the balloon is inflated around the stent/mesh from the small (~0.006’) secondary lumen (50:50 contrast agent and sterile water). Blood flow in the parent vessel is maintained through the deployed stent/mesh and the balloon provides a smooth-consistent seal along the aneurysm neck (figure 1-b). The diameter of the expanded stent is at least 70–80% of the parent vessel artery. Subsequently, after device delivery, the jailed microcatheter is removed. The balloon is deflated, and the stent/mesh is retracted into the microcatheter.
Results The stent-balloon device can temporarily seal off the aneurysm neck during complementary device deployment while maintaining blood flow in the parent vessel, provide a smooth surface at the aneurysm neck to maximize device placement in the aneurysm sac, stop device migration into the parent vessel short-term, and reduce aneurysm recanalization risk long-term. The device with the stent and ultra-high compliant balloon can be used for treating sidewall aneurysms and bifurcation aneurysms where the stent can provide flow in the primary branch while the compliant balloon can seal the aneurysm neck and temporarily occlude the secondary branch.
Conclusion This device can improve the placement of devices, such as coils and a new generation of liquid embolics, into an aneurysm sac without blocking the parent vessel in the short-term, nor leaving metal in the parent vessel long-term. A new stent-balloon device would allow neurointerventionalists a less-restricted time window to deploy embolic devices and obtain a more complete aneurysm sac fill while concurrently limiting any protrusion or migration of the embolic devices downstream.
Disclosures O. Asgari: None. H. Sodawalla: None. T. Becker: None.
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