English
On-X
®
Prosthetic Heart Valve | Instructions for Use
3
LIST OF FIGURES
Figure 1: Aortic and Mitral Profiles ............................................................... 4
Figure 2: Standard or Extended Aortic Valve Holders ................................ 6
Figure 3a: Sizer and Replica Sizer ................................................................. 7
Figure 3b: Sizer ............................................................................................ 7
Figure 4: Instrument Handle ........................................................................ 8
Figure 5: Rotator ........................................................................................... 8
Figure 6: Leaflet Probe ................................................................................. 8
Figure 7a. Twist-off outer lid ........................................................................ 9
Figure 7b. Remove by pull tab... .................................................................. 9
Figure 7c. ...or invert on sterile field.............................................................. 9
Figure 8a. Peel-off outer lid .......................................................................... 9
Figure 8b. Remove by pull tab... ................................................................... 9
Figure 8c. ...or invert on sterile field ............................................................. 9
Figure 9. Opening the inner container .........................................................10
Figure 10. Inserting the instrument handle..................................................10
Figure 11. Aortic replica sizers verify the aortic valve ..................................10
Figure 12. Supra-annular valve positioning .................................................11
Figure 13. Sewing ring cross-sections..........................................................11
Figure 14. Removing the valve holder .........................................................11
Figure 15. Insert valve rotator .....................................................................12
Figure 16. Pivot axis of the mitral valve positioned anti-anatomically .........12
LIST OF CHARTS
Chart 1: Patient Follow-up Over Time .........................................................15
LIST OF TABLES
Table 1: On-X Valve Specifications (millimeters) ........................................... 6
Table 2: Sizer Selections - Regardless of Aortic Holder Type ....................... 7
Table 3: Aortic Replacement Observed Adverse Event Rates ....................15
Table 4: Mitral Replacement Observed Adverse Event Rates .....................16
Table 5: Preoperative Patient Demographics ..............................................16
Table 6: Operative Patient Demographics ..................................................17
Table 7: Number Implanted and Years by Valve Size ...................................18
Table 8: Valve Effectiveness Outcomes .......................................................18
Table 9: Effectiveness Outcomes, Hemodynamic Results ...........................19
