EVERYTHING ABOUT MECHANICAL VALVES HAS · 2017. 7. 31. · Edwards PERIMOUNT Magna Ease Pericardial...

Sizes (mm) 19, 21, 23, 25, 27/29

EVERYTHING ABOUT MECHANICAL VALVES HAS CHANGED

106180.001 CryoLife - New On-X Brochure FIN.indd 1 06/10/2016 14:08

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2

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Why use another mechanical valve when…

1 90° leaflets:1 promotes laminar flow

2 Pure pyrolytic carbon: reduces thrombogenicity2

3 Flared inlet: prevents pannus; organises flow

No other mechanical valve has:

*Reduce INR after 3 months standard therapy1

Step Ahead with On-X Aortic Valve: INR 1.5-2.0*

• 50% closer to a normal INR3

• >60% reduction in bleeding1

• No increase in thromboembolism (TE)1



INR vs. Event Rate5

Mean Gradients at ≥1 Year

On-X Aortic Valve: 50% Closer to a Normal INR3

On-X Aortic Heart Valve patients with an INR of 1.5–2.0 had a >60% reduction in bleeding events and no increase in TE compared to patients with an INR of 2.0–3.0.* All other bileaflet aortic valve anticoagulation should be managed at an INR of 2.0–3.0.4

Optimal HaemodynamicsThe On-X Aortic Heart Valve provides optimal mean gradients compared with other bileaflet and bioprosthetic aortic heart valves at ≥1 year.1,7-11,†

Mean Gradients at ≥1Yr

On-X Aortic Valve1

St. Jude Medical® Regent™7

CarboMedics® Prosthetic Heart Valves8,†

Medtronic® Open Pivot™ Standard, AP**, & AP360**9

Carpentier-Edwards® Perimount® Magna and Magna Ease10

Medtronic® Mosaic® Porcine Bioprosthesis11

25

30

20

15

10

5

0

19 21 23 25 27 29

MeanGradient(mmHg)

From FDA Reviewed Data

Valve Size (mm)

On-

X

On-

X

On-

X

On-

X

On-

XOn-

X

**Medtronic Open Pivot AP and AP360 (formerly ATS): 16 = 19, 18 = 21, 20 = 23, 22 = 25, 24 = 27, 26 = 29 †Postoperative data. Note: Mean gradients for On-X Aortic Valve 27 and 29 were combined.

EventRate(%/pt-yr)

INR

Nor

mal

INR

Rang

e (0

.8-1

.2)6

On-XAorticValveINRRange

All OtherBileafletAortic ValvesINR Range(AHA/ACC)

50

40

30

20

10

0

<1.51.5-2.02.0-2.52.5-3.03.0-3.53.5-4.04.0-4.54.5-5.05.0-5.55.5-6.0≥6.0

Bleeding TE

Pure pyrolytic carbon: reduces thrombogenicity2


On-X Aortic Heart Valve All Other Bileaflet Aortic Heart Valves

90º OpeningOn-X Aortic Heart Valves have leaflets that can open 90º to promote better laminar flow.

<90º OpeningAll other bileaflet aortic heart valves have leaflets that can only open 78º to 85º.9,12

Smoother SurfaceOn-X Aortic Heart Valves have a smoother surface13 on the entire body and leaflets to reduce thrombogenicity.2

Rougher SurfaceAll other bileaflet aortic heart valves have rougher surfaces13 that are more thrombogenic.2

Complete Annulus SupportOn-X Aortic Heart Valves have a flared inlet designed to prevent pannus and conceal pledgets.

Incomplete Annulus SupportAll other bileaflet aortic heart valves have unprotected inlets, allow pannus, and exposes pledgets.

Smooth Pivot2 Rough Machined Pivot2Pure Pyrolytic Carbon2 Silicon Alloyed: Pyrolytic Carbon2


The only aortic mechanical valve FDA and CE approved and clinically proven to be safer with less anticoagulation.*

50% closer to a normal INR.3

INTRODUCING



Learn more at: www.onxlti.com

ML1049.000 (06/2016)

On-X Life Technologies, Inc. is a wholly owned subsidiary of CryoLife, Inc. The On-X prosthetic heart valves are manufactured by On-X Life Technologies, Inc. CryoLife, the snowflake design, Life Restoring Technologies, and On-X are registered trademarks owned by CryoLife, Inc. or its subsidiaries. All other registered trademarks are owned by their respective owners. © 2016 CryoLife, Inc. All rights reserved.

1. On-X Prosthetic Heart Valve Instructions for Use. 2. LaGrange L et al., Compatibility of carbon and blood. Hegyeli RJ, Editor, Proceedings, Artificial Heart Program Conference, Washington, DC, June 9-13, 1969, 47-58. 3. Normal INR is considered 1. WHO Expert Committee on Biological Standardization, 33rd Report, World Health Organization, 1983. http://apps.who.int/iris/bitstream/10665/39217/1/WHO_TRS_687.pdf, downloaded on 06/29/2016. 4. Nishimura R et al., 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014;63: e57–185. 5. Data on file. 6. Levine M et al., Monitoring of international normalized ratios: comparison of community nurses with family physicians. Can Fam Physician 2012;58:e465-71. 7. St. Jude Medical Physician’s Manual Mechanical Heart Valve. 8. CarboMedics Prosthetic Heart Valve Instructions for Use. 9. Medtronic Open Pivot Heart Valve Instructions for Use. 10. Edwards Life Sciences Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis Model 3300TFX Instructions for Use. 11. Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use. 12. Kandemir O et al., St. Jude Medical and Carbomedics mechanical heart valves in the aortic position comparison of long term results. Tex Heart Inst J. 2006; 33: 154–159. 13. More R and Haubold A. Surface chemistry and surface roughness of clinical pyrocarbons. Cell Mater. 1996;6: 273-79. 14. Korteland N et al., Quality of life and prosthetic aortic valve selection in non-elderly adult patients. Interact Cardiovasc Thorac Surg. 2016; 22: 723-728. 15. Yanagawa B et al., Anticoagulation for prosthetic heart valves: unresolved questions requiring answers. Curr Opin Cardiol. 2016; 31: 176–182. 16. Coumadin Labeling on FDA website. http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009218s108lbl.pdf, downloaded on 05/24/2016.

On-X Aortic Valve Patients

Fred Hoiberg, Age 43

Head Coach: Chicago Bulls On-X Aortic Valve Recipient

“I couldn’t be happier with everything involved. First of all, getting the mechanical

valve and second getting the On-X valve. The way I feel now, after the valve replacement, I feel like I did when I was playing. I feel great, and I’m thankful I got the valve that I did.”

“The On-X aortic valve would allow me to take lower blood thinner levels

[… and] continuing my cycling activities for many years to come.”

Note: Outcomes may vary per patient.

Mike, Age 54

Competitive Cyclist On-X Aortic Valve Recipient

“[…] The balance between valve durability versus risk of bleeding and thromboembolic events favors the choice of a mechanical valve in patients <60 years of age.”(2014 AHA/ACC Guidelines)4

Anatomic Conform-X StandardSizes (mm) 19, 21, 23, 25, 27/29

On-X Aortic Heart Valve Configurations

Patients who are:• ≤70 years (2014 AHA/ACC Guidelines)4

• Anticipated to be on long-term warfarin therapy (e.g. chronic Afib or DVT)4,15,16

Patients who desire:• An active lifestyle

• The lowest warfarin therapy of all mechanical aortic valves*

• Durability: not being afraid of having a future aortic valve reoperation4,13 *Reduce INR after 3 months standard therapy1

Bramley House • The Guildway Old Portsmouth Road Guildford, Surrey GU3 1LR United KingdomTel: +44 (0) 1483 441030 • Fax: +44 (0) 1483 452860Email: [email protected]

On-X Life Technologies, Inc. 1300 East Anderson Lane • Bldg. BAustin, Texas 78752 USA Tel: (512) 339-8000 • Fax: (512) 339-3636 Email: [email protected]

CryoLife, Inc. 1655 Roberts Boulevard • NW, Kennesaw, Georgia, USA 30144Tel: 888-427-9654 • Fax: 770-590-3753Email: [email protected]

Emergo EuropeMolenstraat 15, 2513 BH The Hague, The Netherlands


EVERYTHING ABOUT MECHANICAL VALVES HAS · 2017. 7. 31. · Edwards PERIMOUNT Magna Ease Pericardial...

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