Aortic Valve Stenosis
To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.
CRITERIA LIST/ QUALIFICATIONS:
- Patient has moderate or greater aortic stenosis or regurgitation, and there is clinical indication for replacement of their native or prosthetic aortic valve with a bioprosthesis, with or without concomitant procedures.
- Patient is geographically stable and willing to return to the implanting site for all follow-up visits.
Vibhu Kshettry, MD