title: Final results of the multicenter, prospective Axium MicroFX for Endovascular Repair of IntraCranial Aneurysm Study (AMERICA).
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.
authors.affiliation: Department of Neurosurgery, University of Florida, Gainesville, Florida, USA.
authors.forename: Kyle M
authors.initials: KM
authors.lastname: Fargen
authors.affiliation: Department of Neurosurgery, University of Florida, Gainesville, Florida, USA.
authors.forename: Spiros
authors.initials: S
authors.lastname: Blackburn
authors.affiliation: Department of Neurosurgery, SUNY Upstate University Hospital, Syracuse, New York, USA.
authors.forename: Eric M
authors.initials: EM
authors.lastname: Deshaies
authors.affiliation: Department of Radiology, West Virginia School of Medicine, Morgantown, West Virginia, USA.
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Carpenter
authors.affiliation: Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
authors.forename: Pascal
authors.initials: P
authors.lastname: Jabbour
authors.affiliation: Department of Neurosurgery, University of Southern California, Los Angeles, California, USA.
authors.forename: William J
authors.initials: WJ
authors.lastname: Mack
authors.affiliation: Department of Radiology, West Virginia School of Medicine, Morgantown, West Virginia, USA.
authors.forename: Ansaar T
authors.initials: AT
authors.lastname: Rai
authors.affiliation: Department of Neurosurgery, University at Buffalo, Buffalo, New York, USA.
authors.forename: Adnan H
authors.initials: AH
authors.lastname: Siddiqui
authors.affiliation: Department of Neurosurgery, Medical University of South Carolina, Charleston, South Carolina, USA.
authors.forename: Raymond D
authors.initials: RD
authors.lastname: Turner
authors.affiliation: Department of Neurosurgery, Vanderbilt University, Nashville, Tennessee, USA.
authors.forename: J
authors.initials: J
authors.lastname: Mocco
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020099:Coated Materials, Biocompatible / Q000009:adverse effects / Q000627:therapeutic use*; D004621:Embolization, Therapeutic / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D002532:Intracranial Aneurysm / Q000000981:diagnostic imaging / Q000628:therapy*; D019344:Lactic Acid; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011091:Polyesters; D011100:Polyglycolic Acid; D011108:Polymers; D011859:Radiography; D055815:Young Adult
chemical_list: D020099:Coated Materials, Biocompatible; D011091:Polyesters; D011108:Polymers; D011100:Polyglycolic Acid; D019344:Lactic Acid; C033616:poly(lactide)
keywords: Aneurysm; Coil; Device