ATS 3f(r) Aortic Bioprosthesis Model 1000, 19mm

Exclusion Criteria

• •This patient is twenty (20) or less than twenty years of age.
• •This patient has a non-cardiac major or progressive disease, which in the investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than 12 months.
• •This patient is an intravenous drug and/or alcohol abuser.
• •This female patient is pregnant (urine HCG test result positive), or lactating.
• •This patient presents with active endocarditis.
• •This patient presents with congenital bicuspid aortic anatomy.
• •This patient has a previously implanted prosthetic valve that is not being replaced by a study valve.
• •This patient requires mitral, tricuspid or pulmonic valve replacement.
• •This patient is participating in concomitant research studies of investigational products.
• •This patient will not agree to return to the implant center for the required number of follow-up visits or is geographically unavailable for follow-up.