The data collected in this study will be used to support International Regulatory submissions. The study objective is to evaluate the continued safety and efficacy of the AXIUM Progressive Coil System. This Device has been used clinically at approximately 150 Institutions under FDA 510(k) clearance since April 24, 2007. The device received CE authorization on June 30, 2007. Through December 2007, more than 1000 patients have been treated with the AXIUM Coils.
Study Type
OBSERVATIONAL
Enrollment
119
Embolization of aneurysm
Lac+Usc/Uscuh
Los Angeles, California, United States
Vascular and Interventional Specialists of Orange County, Inc. - St. Joseph Hospital of Orange
Orange, California, United States
Lee Memorial Health System
Fort Myers, Florida, United States
University of Miami - Jackson Memorial Hospital Systems
Miami, Florida, United States
Bayfront Medical Center
St. Petersburg, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Neurologic & Orthopedic Hospital of Chicago (NOHC)
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Massachusetts Medical Center
Worcester, Massachusetts, United States
Abbott Northwestern
Minneapolis, Minnesota, United States
...and 8 more locations
Percent Occlusion
Time frame: Defined in protocol
Morbidity/Mortality
Time frame: Defined in protocol
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