FDA clears first stapling system to repair failed aortic grafts
November 22, 2011 by MassDevice staff
Aptus Endosystems lands FDA clearance for the first system to repair aortic grafts that migrate, leak or are at risk of doing either.
Aptus Endosystems Inc. landed FDA 510(k) clearance for the first repair system designed to fix leaks and migration in implanted endografts.
An endograft is a tube used to repair a bulge in the wall of the large blood vessel that carries blood away from the heart. Aptus' HeliFX is a minimally invasive system of staples, delivered via catheter, that allows a surgeon to reach the blood vessel and staple the top edges of the endograft to the tissue to anchor it in place.
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