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Final results of the multicenter, prospective Axium MicroFX for Endovascular Repair of IntraCranial Aneurysm Study (AMERICA)
  1. Kyle M Fargen1,
  2. Spiros Blackburn1,
  3. Eric M Deshaies2,
  4. Jeffrey S Carpenter3,
  5. Pascal Jabbour4,
  6. William J Mack5,
  7. Ansaar T Rai3,
  8. Adnan H Siddiqui6,
  9. Raymond D Turner7,
  10. J Mocco8
  1. 1Department of Neurosurgery, University of Florida, Gainesville, Florida, USA
  2. 2Department of Neurosurgery, SUNY Upstate University Hospital, Syracuse, New York, USA
  3. 3Department of Radiology, West Virginia School of Medicine, Morgantown, West Virginia, USA
  4. 4Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA
  5. 5Department of Neurosurgery, University of Southern California, Los Angeles, California, USA
  6. 6Department of Neurosurgery, University at Buffalo, Buffalo, New York, USA
  7. 7Department of Neurosurgery, Medical University of South Carolina, Charleston, South Carolina, USA
  8. 8Department of Neurosurgery, Vanderbilt University, Nashville, Tennessee, USA
  1. Correspondence to Dr Kyle M Fargen, Department of Neurosurgery, University of Florida, Gainesville, Box 100265, Gainesville, FL 32610, USA; kyle.fargen{at}neurosurgery.ufl.edu

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.

  • Aneurysm
  • Coil
  • Device

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