On-X On-X Aortic Heart Valve and Extended Holder Instructions For Use Manual Download Page 20

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On-X Life Technologies, Inc.

1300 East Anderson Lane, Bldg. B Austin, Texas 78752 U.S.A.
TEL: (512) 339-8000 FAX: (512) 339-3636
WEB: www.onxlti.com EMAIL: [email protected]

CryoLife Europa, Ltd.

Bramley House, The Guildway, Old Portsmouth Road
Guildford, Surrey, GU3 1LR, United Kingdom

010122 103 A (06/2017)

Moist Heat (Steam)

Summary of Contents for On-X Aortic Heart Valve and Extended Holder

Page 1: ...eart Valve with Conform X Sewing Ring REF ONXAC On X Mitral Heart Valve with Conform X Sewing Ring REF ONXMC On X Aortic Heart Valve with Anatomic Sewing Ring REF ONXAN On X Aortic Heart Valve and Ext...

Page 2: ...SSMENT AND VALVE ROTATION 11 9 7 VALVE ORIENTATION 12 10 POSTOPERATIVE INFORMATION 12 10 1 MAGNETIC RESONANCE IMAGING MRI COMPATIBILITY 12 10 2 RETURNED GOODS 12 11 PATIENT INFORMATION 12 11 1 PATIENT...

Page 3: ...eplica 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 F...

Page 4: ...a travel arc of 50 to the closed position The orifice is composed of graphite substrate coated with On X Carbon a pure unalloyed form of pyrolytic carbon The leaflets consist of On X Carbon deposited...

Page 5: ...esis regurgitation prosthesis structural dysfunction prosthesis thrombosis stroke thromboembolism It is possible that these complications could lead to reoperation explantation permanent disability de...

Page 6: ...rded on the outer package label Appropriate inventory control should be maintained so that prostheses with earlier expiration dates are preferentially implanted and expiration is avoided To protect th...

Page 7: ...YES Intrasupra annular 23 Aortic Cylindrical YES Intrasupra annular 25 Aortic Cylindrical YES Intrasupra annular 27 29 Aortic Conical YES Intra annular 19 Aortic Conform X Cylindrical YES Intrasupra...

Page 8: ...n and Resterilization The On X Prosthetic Heart Valve is provided sterile If the sterility expiration date has passed or if upon removal from the outer box the valve container is damaged or the steril...

Page 9: ...the patient or place it in the patient s records Figure 7a Twist off outer lid Figure 7b Remove by pull tab Figure 7c or invert on sterile field 4 Open the outer container Twist off outer lid package...

Page 10: ...thetic Heart Valve sizers when sizing the annulus Sizers contain cylindrical conical and aortic replica ends Refer to Table 2 to facilitate sizer selection Cylindrical sizers correspond to the valve s...

Page 11: ...mplanted using a pledgetted or non pledgetted everting mattress suture technique although non everting and continuous suture techniques have also been used with success CAUTION When seating the valve...

Page 12: ...e to rotation is encountered The torque required to rotate the valve in situ should be about the same as that required when testing rotation before implantation If noticeably greater torque is require...

Page 13: ...mplete the card and carry it with them at all times 11 3 Patient Information Booklet On XLTI has made available a patient information booklet that the physician may choose to provide to the patient pr...

Page 14: ...s in an international multicenter prospective non randomized study with retrospective controls Patients requiring isolated mitral heart valve replacement were enrolled from 1996 to 2001 at 16 centers...

Page 15: ...d as linearized rates based on total patient years 3 Freedom from event was calculated based on the method of Kaplan Meier SE Standard Error 4 n number of patients in each category N total number of s...

Page 16: ...3 0 7 99 0 0 7 99 0 0 7 Explant 1 0 4 3 0 7 98 0 1 0 98 0 1 0 Hemolysis5 0 0 0 0 0 0 100 0 0 100 0 0 Hemorrhage6 all 4 1 8 6 1 4 96 4 1 3 94 4 2 0 Hemorrhage major 4 1 8 2 0 5 97 0 1 2 97 0 1 2 Periv...

Page 17: ...tis 18 7 8 Gastroinestinal Ulcer 18 7 8 Chronic Kidney Failure 13 5 6 Carotid Artery Disease 12 5 2 Coronary Artery Bypass Graft 10 4 4 Cancer 10 4 4 Previous Mitral Valve Replacement 9 3 9 Cardiomyop...

Page 18: ...ts followed reproduced from Figure 2 Nd number of patients for which NYHA data were collected not including missing 3 n number of patients in each category 4 Undetermined means data were collected but...

Page 19: ...2 0 4 3 Regurgitation Nd 20 Nd 37 Nd 68 Nd 36 Nd 25 n n Nd n n Nd n n Nd N n Nd n n Nd 0 5 25 0 9 24 3 27 39 7 17 47 2 7 28 0 1 2 12 60 0 25 67 6 37 54 4 16 44 4 17 68 0 3 2 10 0 0 0 0 3 4 4 2 5 6 1 4...

Page 20: ...Bldg B Austin Texas 78752 U S A TEL 512 339 8000 FAX 512 339 3636 WEB www onxlti com EMAIL onx onxlti com CryoLife Europa Ltd Bramley House The Guildway Old Portsmouth Road Guildford Surrey GU3 1LR Un...