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AGA Medical Corp.
Study compares Amplatzer PFO Occluder and standard drug treatment
July 30th, 2003
AGA Medical Corporation announced the start of enrollment for a major clinical trial to evaluate whether transcatheter closure of a common heart defect, patent foramen ovale (PFO), using the implantable Amplatzer PFO Occluder is superior to standard of care medical treatment in preventing recurrent stroke or transient ischemic attack (TIA) in patients with PFO. The RESPECT clinical trial (Randomized Evaluation of Recurrent Stroke comparing PFO Closure to Established Current Standard of Care Treatment) is the first of its kind unconditionally approved by the U.S. Food and Drug Administration (FDA). The trial will include a maximum of 45 medical institutions and 500...
Source: Biotech Week (2003-07-30)
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