2 results
Approved WMOCompleted
Primary clinical investigation objectives[Safety]The primary safety objective of the clinical investigation is to provide data that demonstrates safety of the device, defined as < 8.3% serious adverse device effects, up to 6 weeks following…
Not approvedWill not start
To evaluate the safety and effectiveness of the ATS 3f Enable* Aortic Bioprosthesis equine pericardial stented bioprosthesis in a patient population undergoing isolated aortic valve replacement with or without concomitant procedures.