CryoValve SG Pulmonary Human Heart Valve Post Clearance Study

The CryoValve SG pulmonary human heart valve is recovered from deceased human donors,
treated with the SynerGraft® process,which is designed to reduce the donor cells present on
the graft. The valve is then cryopreserved for storage until use. Removing cells from the
heart valve has been shown to reduce a component of the immune response after implant
compared to a standard allograft valve. However, it is not known how this affects the
long-term durability of the valve.

• Retrospective Patients

o Sequential patients implanted with a CryoValve SG Pulmonary Human Heart Halve as a Ross
or RVOT reconstruction between February 2000 and March 2004 who were included in the
510(k) data collection will be identified using the following general criteria to aid in
selection of patients who are most likely to provide adequate follow-up data: Patient is
alive and the implanted valve is still in place (has not been explanted).

Patient is still under the care of the implanting institution or the implanting surgeon.

Patient was identified as previously providing data for at least one echocardiographic
follow-up assessment at a minimum of one year post-implant.

- Additionally, prospective enrolling centers will have the option to enroll
retrospective patients. At these centers, all consecutive patients identified from
valve implant data at CryoLife, implanted with a CryoValve SG Pulmonary Valve as a
valved pulmonary valve prior to Clearance in 2008 will be targeted for inclusion in
the retrospective patient data collection.

• Prospective Patients

- Sequential patients implanted with a CryoValve SG Pulmonary Human Heart Halve as a
Ross or RVOT reconstruction after FDA 510(k) clearance in February 2008 at selected
institutions.