Format

Send to

Choose Destination
J Neurointerv Surg. 2015 Jan;7(1):40-3. doi: 10.1136/neurintsurg-2013-011049. Epub 2014 Jan 6.

Final results of the multicenter, prospective Axium MicroFX for Endovascular Repair of IntraCranial Aneurysm Study (AMERICA).

Author information

1
Department of Neurosurgery, University of Florida, Gainesville, Florida, USA.
2
Department of Neurosurgery, SUNY Upstate University Hospital, Syracuse, New York, USA.
3
Department of Radiology, West Virginia School of Medicine, Morgantown, West Virginia, USA.
4
Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
5
Department of Neurosurgery, University of Southern California, Los Angeles, California, USA.
6
Department of Neurosurgery, University at Buffalo, Buffalo, New York, USA.
7
Department of Neurosurgery, Medical University of South Carolina, Charleston, South Carolina, USA.
8
Department of Neurosurgery, Vanderbilt University, Nashville, Tennessee, USA.

Abstract

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. Trial endpoints were 3-6 month angiographic occlusion and clinical status, as reported by treatment center.

RESULTS:

Mean follow-up was 157.9 days (median 153.5, range 1-445, SEM 9.3 days). At last follow-up imaging, 90.6% of all aneurysms, 90% of unruptured aneurysms, and 93.3% of ruptured aneurysms had Raymond grade I or II occlusion. Progression to further occlusion (lower Raymond occlusion grade) occurred in 29/85 aneurysms (34.1%). Aneurysm recurrence occurred in 11/85 aneurysms (12.9%). Ninety-nine per cent of patients treated electively and 68.7% of ruptured patients had a modified Rankin score of 0-2. Delayed adverse events (AEs), occurring after discharge and during the follow-up period, occurred in 10% of patients. In total, two AEs (one severe and one moderate) were potentially related to the device, thereby providing a 2% device-related AE rate.

CONCLUSIONS:

In this prospective, multicenter series of 100 aneurysms treated with Axium MicroFX PGLA (polyglycolic/polylactic acid) coils, 3-6 month angiographic occlusion and clinical outcomes were excellent. This study suggests that Axium MicroFX PGLA coils are safe and effective in the treatment of intracranial aneurysms.

KEYWORDS:

Aneurysm; Coil; Device

PMID:
24394153
DOI:
10.1136/neurintsurg-2013-011049
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for HighWire
Loading ...
Support Center