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On-X
Prosthetic Heart Valve
Instructions for Use
English
On-X
Aortic Heart Valve with Standard Sewing Ring - REF ONXA
®
On-X
Mitral Heart Valve with Standard Sewing Ring - REF ONXM
®
On-X
®
Aortic Heart Valve with Conform-X
On-X
Mitral Heart Valve with Conform-X
®
On-X
Aortic Heart Valve with Anatomic Sewing Ring - REF ONXAN
®
On-X
Aortic Heart Valve and Extended Holder - REF ONXAE
®
On-X
Aortic Heart Valve with Conform-X
®
On-X
Aortic Heart Valve with Anatomic Sewing Ring and Extended Holder - REF ONXANE
®
®
®
Sewing Ring - REF ONXAC
Sewing Ring - REF ONXMC
®
Sewing Ring and Extended Holder - REF ONXACE
®
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Table of Contents
Related Manuals for On-X On-X Mitral Heart Valve with Standard Sewing Ring
Summary of Contents for On-X On-X Mitral Heart Valve with Standard Sewing Ring
- Page 1 On-X ® 0 4 5 9 Prosthetic Heart Valve Instructions for Use English On-X Aortic Heart Valve with Standard Sewing Ring - REF ONXA ® On-X Mitral Heart Valve with Standard Sewing Ring - REF ONXM ® On-X ® Aortic Heart Valve with Conform-X ®...
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Page 2: Table Of Contents
English ON-X PROSTHETIC TABLE OF CONTENTS ® HEART VALVE ON-X PROSTHETIC HEART VALVE ............2 ® INSTRUCTIONS FOR USE INSTRUCTION FOR USE ................. 4 1. DEVICE DESCRIPTION ..............4 2. INDICATIONS FOR USE ..............4 On-X Aortic Heart Valve with ®... - Page 3 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...
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Page 4: On-X ® Prosthetic Heart Valve
(mounting) diameter (A) supra-annular sewing ring position. profile height open (H) profile height closed (h) 2. INDICATIONS FOR USE The On-X Prosthetic Heart Valve is indicated for the (E) MITRAL CONFORM-X (ONXMC) ® replacement of diseased, damaged, or malfunctioning... -
Page 5: On-X
4.1 Warnings • thromboembolism FOR SINGLE USE ONLY. It is possible that these complications could lead to: DO NOT use the On-X Prosthetic Heart Valve if: • reoperation • the prosthesis has been dropped, damaged, or • explantation mishandled in any way;... -
Page 6: How Supplied
8.1 Available Models and Sizes shown in Table 1 and Figure 1. The symbol SZ mm on The On-X Prosthetic Heart Valve is available in 3 aortic the box, container labels, and implant registration card and 2 mitral sewing ring configurations. All aortic... -
Page 7: Accessories
English 8.4 Accessories Replica Sizers The On-X Prosthetic Heart Valve is designed to be used Aortic replica sizers are provided for all aortic valve only with On-XLTI On-X instruments. The instruments, sizes (Figure 3a). They model the On-X standard aortic supplied separately, are provided as a set, which valve profile. -
Page 8: Accessory Cleaning And Sterilization
The leaflet probe may be used to gently move the 9.1 Physician Training leaflets to verify that they open and close freely. No special training is required to implant the On-X Prosthetic Heart Valve. The techniques for implanting this prosthesis are similar to those used for any Figure 4: Instrument Handle mechanical heart valve prosthesis. -
Page 9: Figure 7A. Twist-Off Outer Lid
4. Open the outer container 1. Check the expiration date on the outer box. WARNING: DO NOT use the On-X Prosthetic Heart Twist-off outer lid package design: Rotate the lid Valve if the expiration date has elapsed. If a valve counter-clockwise until it stops, then lift the lid off off of the container (Figure 7a). -
Page 10: Device Implantation
Sizing Carefully grasp the sewing ring with a gloved hand Use only On-X Prosthetic Heart Valve sizers when sizing using a light grip and gently turn the instrument the annulus. Sizers contain cylindrical, conical, and aortic handle in either direction. -
Page 11: Suturing Techniques
Figure 13. Sewing ring cross-sections be placed in an intra-annular position and have a replica Housing sizer to mimic this placement. All mitral valves, including the On-X Mitral Conform-X Titanium Prosthetic Heart Valve, are designed to be placed in a Aortic... -
Page 12: Leaflet Motion Assessment And Valve Rotation
WARNING: Test the leaflet mobility only with the CAUTION: Once the valve is implanted, visually On-XLTI On-X leaflet probe or the leaflet probe on confirm that the coronary ostia are free from the end of the rotator. potential interference. -
Page 13: Returned Goods
Copies of this booklet the position of the On-X Mitral Conform-X Heart Valve are available on request from your On-XLTI sales Prosthesis, Size 25-33. Therefore, optimization of MR representative. -
Page 14: Adverse Events
New York Heart Association (NYHA) 1. ADVERSE EVENTS classification and echocardiographic assessments. A total of 184 aortic On-X Prosthetic Heart Valves were NYHA and blood data were obtained pre-operatively, implanted in 184 patients at 11 centers. The mean intra-operatively, and post-operatively at 3 to 6 months, follow-up was 2.2 years (range of 0 to 4.0 years) with a... -
Page 15: Chart 1: Patient Follow-Up Over Time
1-year, and all other analytes within normal range. 6. The anticoagulant agents used were reported. The target International Normalized Ratio was 2.5 to 3.5 in AVR and 3.0 to 4.5 in MVR. On-X Prosthetic Heart Valve | Instructions for Use... -
Page 16: Table 4: Mitral Replacement Observed Adverse Event Rates
Notes: 1. n = number of patients in each category; N = total number Notes: 1. n = number of patients in each category; N = total number of study of study patients. patients. On-X Prosthetic Heart Valve | Instructions for Use ®... -
Page 17: Table 6: Operative Patient Demographics
1. Ordered by frequency of occurrence, except for valve size. 2. n = number of patients in each category; N = total number of study patients. 3. May be more than one per patient. On-X Prosthetic Heart Valve | Instructions for Use ®... -
Page 18: Table 7: Number Implanted And Years By Valve Size
4. Undetermined means data were collected but Class could not be determined during exam 5. Missing refers to the difference between the number of patients followed, Nf, and the number of patients for which NYHA data were collected, Nd. On-X Prosthetic Heart Valve | Instructions for Use ®... -
Page 19: Table 9: Effectiveness Outcomes, Hemodynamic Results
6. Regurgitation represents the valvular backflow of blood due to normal leakage and perivalvular leakage; 0 = none, 1+ = mild, 2+ = moderate, 3+ = moderate/severe, 4+ = severe. 7. n = number of patients in each category. On-X Prosthetic Heart Valve | Instructions for Use ®... - Page 20 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: onx@onxlti.com CryoLife Europa, Ltd. Bramley House, The Guildway, Old Portsmouth Road Guildford, Surrey, GU3 1LR, United Kingdom...
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