Aneurysm
Lombard Medical Announces Filing of Supplemental IDE to Pivotal US Clinical Trial for Aorfix and Provides Progress Update
Published in Medical Letter on the CDC and FDA, May 13th, 2007
Lombard Medical Technologies PLC ("Lombard Medical") has filed a supplement to its investigational device exemption (IDE) application with respect to the pivotal US clinical trial of its Aorfix(tm) endovascular stent graft in the treatment of abdominal aortic aneurysms (AAAs). This supplemental IDE requests permission to widen the trial entry criteria to include patients with aneurysm neck angulations of up to 90', to increase the number of trial centres to twenty and to reduce the overall number of enrolled patients from 385 to 220. The changes proposed are expected to be reviewed by the FDA in the next five weeks.
These changes follow discussions with clinical...
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