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Examples
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New Liturgical Movement: What is Alius Cantus Aptus? skip to main | skip to sidebar
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Aptus ' s U.S. clinical study of the product lured some top vascular doctors, including study co-directors Ronald M. Fairman , a University of Pennsylvania vascular surgery professor, and vascular surgeon Manish Mehta of Albany Medical Center in New York.
Stent-Graft Study Points to Gap in Oversight Thomas M. Burton 2010
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Jeff Elkins, chief executive of Aptus, said in interviews that the FDA didn ' t inspect the company ' s manufacturing facility.
Stent-Graft Study Points to Gap in Oversight Thomas M. Burton 2010
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The FDA didn ' t inspect or audit the plant where the devices were made before they were placed in the aortas of more than 175 study participants, according to information from Aptus and from presentations at medical conferences.
Stent-Graft Study Points to Gap in Oversight Thomas M. Burton 2010
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An FDA spokesman declined to comment on the Aptus case.
Stent-Graft Study Points to Gap in Oversight Thomas M. Burton 2010
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The Aptus device has been approved by European regulators for clinical use and the company has begun putting it into patients there.
Stent-Graft Study Points to Gap in Oversight Thomas M. Burton 2010
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Aptus declined to comment on that particular case.
Stent-Graft Study Points to Gap in Oversight Thomas M. Burton 2010
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The Aptus stent-graft, called Aptus AAA Endovascular Repair System, appears to have some potential advantages over rival devices, including a smaller profile that allows it to more easily slide into place, according to doctors who have treated aortic- aneurysm patients.
Stent-Graft Study Points to Gap in Oversight Thomas M. Burton 2010
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The stent-graft device developed by Aptus of Sunnyvale, Calif., was designed to treat aortic aneurysms, which are bulges in the aorta, the main artery carrying blood through the abdomen to vital organs.
Stent-Graft Study Points to Gap in Oversight Thomas M. Burton 2010
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According to doctors knowledgeable about the study, some of the Aptus stent-grafts were sewn together incorrectly so clots formed, blocking circulation and in some cases floating down into legs.
Stent-Graft Study Points to Gap in Oversight Thomas M. Burton 2010
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