PMID- 24394153
OWN - NLM
STAT- MEDLINE
DCOM- 20160215
LR  - 20220410
IS  - 1759-8486 (Electronic)
IS  - 1759-8478 (Linking)
VI  - 7
IP  - 1
DP  - 2015 Jan
TI  - Final results of the multicenter, prospective Axium MicroFX for Endovascular 
      Repair of IntraCranial Aneurysm Study (AMERICA).
PG  - 40-3
LID - 10.1136/neurintsurg-2013-011049 [doi]
AB  - 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.
CI  - Published by the BMJ Publishing Group Limited. For permission to use (where not 
      already granted under a licence) please go to 
      http://group.bmj.com/group/rights-licensing/permissions.
FAU - Fargen, Kyle M
AU  - Fargen KM
AD  - Department of Neurosurgery, University of Florida, Gainesville, Florida, USA.
FAU - Blackburn, Spiros
AU  - Blackburn S
AD  - Department of Neurosurgery, University of Florida, Gainesville, Florida, USA.
FAU - Deshaies, Eric M
AU  - Deshaies EM
AD  - Department of Neurosurgery, SUNY Upstate University Hospital, Syracuse, New York, 
      USA.
FAU - Carpenter, Jeffrey S
AU  - Carpenter JS
AD  - Department of Radiology, West Virginia School of Medicine, Morgantown, West 
      Virginia, USA.
FAU - Jabbour, Pascal
AU  - Jabbour P
AD  - Department of Neurosurgery, Thomas Jefferson University, Philadelphia, 
      Pennsylvania, USA.
FAU - Mack, William J
AU  - Mack WJ
AD  - Department of Neurosurgery, University of Southern California, Los Angeles, 
      California, USA.
FAU - Rai, Ansaar T
AU  - Rai AT
AD  - Department of Radiology, West Virginia School of Medicine, Morgantown, West 
      Virginia, USA.
FAU - Siddiqui, Adnan H
AU  - Siddiqui AH
AD  - Department of Neurosurgery, University at Buffalo, Buffalo, New York, USA.
FAU - Turner, Raymond D
AU  - Turner RD
AD  - Department of Neurosurgery, Medical University of South Carolina, Charleston, 
      South Carolina, USA.
FAU - Mocco, J
AU  - Mocco J
AD  - Department of Neurosurgery, Vanderbilt University, Nashville, Tennessee, USA.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20140106
PL  - England
TA  - J Neurointerv Surg
JT  - Journal of neurointerventional surgery
JID - 101517079
RN  - 0 (Coated Materials, Biocompatible)
RN  - 0 (Polyesters)
RN  - 0 (Polymers)
RN  - 26009-03-0 (Polyglycolic Acid)
RN  - 33X04XA5AT (Lactic Acid)
RN  - 459TN2L5F5 (poly(lactide))
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Coated Materials, Biocompatible/adverse effects/*therapeutic use
MH  - Embolization, Therapeutic/adverse effects/*instrumentation/methods
MH  - Endovascular Procedures/adverse effects/*instrumentation/methods
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Intracranial Aneurysm/diagnostic imaging/*therapy
MH  - Lactic Acid
MH  - Male
MH  - Middle Aged
MH  - *Outcome Assessment, Health Care
MH  - Polyesters
MH  - Polyglycolic Acid
MH  - Polymers
MH  - Radiography
MH  - Young Adult
OTO - NOTNLM
OT  - Aneurysm
OT  - Coil
OT  - Device
EDAT- 2014/01/08 06:00
MHDA- 2016/02/16 06:00
CRDT- 2014/01/08 06:00
PHST- 2014/01/08 06:00 [entrez]
PHST- 2014/01/08 06:00 [pubmed]
PHST- 2016/02/16 06:00 [medline]
AID - neurintsurg-2013-011049 [pii]
AID - 10.1136/neurintsurg-2013-011049 [doi]
PST - ppublish
SO  - J Neurointerv Surg. 2015 Jan;7(1):40-3. doi: 10.1136/neurintsurg-2013-011049. 
      Epub 2014 Jan 6.