Axium PGLA

BACKGROUND: Embolic coils have been used to treat intracranial aneurysms using an endovascular approach for more than two decades. However, significant aneurysm recanalization rates have been reported specifically in large and giant aneurysms. Adding filaments to bare Platinum coils is considered a modification and has been proposed to achieve higher aneurysm occlusion rates as compared to bare Platinum coils. Quantitative information - in terms of thrombin generation potential of these modifications - is however lacking...

BACKGROUND: We previously performed a multicenter prospective single-arm trial of 100 patients treated with Axium MicroFX Coils (ev3; Plymouth, Minnesota, USA), AMERICA: Axium MicroFX for Endovascular Repair of IntraCranial Aneurysm study. Initial angiographic and clinical outcomes were excellent. The final results are presented herein. METHODS: AMERICA is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the ev3 Axium MicroFX coil system in 100 separate aneurysms between April 2010 and October 2012...

BACKGROUND: Axium MicroFX coils contain polymer (polyglycolic/polylactic acid, PGLA) microfilaments designed to significantly impact intra-aneurysmal flow and to encourage aneurysm thrombosis. To provide preliminary evaluation of the safety and suggested efficacy of the MicroFX design, we performed a multicenter prospective single-arm trial, Axium MicroFX for Endovascular Repair of IntraCranial Aneurysm study (AMERICA). METHODS: AMERICA is a prospective multicenter 100 aneurysm observational study evaluating the safety and efficacy of Axium MicroFX PGLA coils...

Recanalization of previously coiled aneurysms remains a major drawback of endovascular aneurysm therapy. We performed a prospective single arm trial to provide early initial data regarding the safety and angiographic durability of a new coil technology, the Axium MicroFX Polyglycolic/polylactic acid (PGLA) coil, which was designed to lower recanalization rates. Fifteen patients (16 aneurysms) were prospectively enrolled. Demographic and peri-procedural data were collected. Angiographic images of the initial coil embolization and three to six month follow-up angiographic images underwent blinded evaluation...