Clinical Results

Clinical Results

 

2001 US FDA approves On-X Aortic Valve
2002 US FDA approves On-X Mitral Valve
2006 US FDA approves IDE lowered anticoagulation clinical for the On-X heart valve. Prospective Randomized On-X Valve Anticoagulation Clinical Trial (PROACT) is initiated.
2009 Enrollment complete in the high-risk aortic patient group of the Prospective Randomized On-X Valve Anticoagulation Clinical Trial (PROACT).
2011 US FDA approves On-X Ascending Aortic Prosthesis
2013 US FDA approves Chord-X™ ePTFE suture for mitral valve repair and replacement
2013 US FDA approves On-X aortic heart valve with anatomic sewing cuff
2013 Enrollment complete in the low-risk aortic patient group and the mitral patient group of the Prospective Randomized On-X Valve Anticoagulation Clinical Trial (PROACT)
2015 US FDA approves On-X aortic heart valves with INR 1.5–2.0 after 3 months standard anticoagulation, based on results from the high risk AVR group of the Prospective Randomized On-X Valve Anticoagulation Clinical Trial (PROACT)

FDA Clinical Results

 
Hemolysis

Postoperative serum lactate dehydrogenase (SLDH) levels are in the normal range, indicating minimal hemolysis8.

Upper normal = 250

Valve 3-6 Months 1 Year 2 Years
Aortic 222 225 229
Mitral 262 253 261
Double 238 246 243

 

Morbid Event Rates

FDA clinical trials for the On-X valve produced the lowest morbid event rates of all carbon valves. The following tables compare On-X clinical data with those of other valves.

On-X Morbid Event Rates Comparison – Aortic Position (% per pt-year)

Event On-X1 SJM2 CMI3 ATS4 MH2
Thromboembolism 1.03 1.71 1.11 2.08 1.50
Thrombosis 0 0.19 0.03 0.00 0.20
Hemorrhage 0.59 2.00 1.82 1.96 0.80
Totals 1.62 3.90 2.96 4.04 2.50

 

On-X Morbid Event Rates Comparison – Mitral Position (% per pt-year)

Event On-X1 SJM2 CMI3 ATS4 MH2
Thromboembolism 1.00 1.86 2.05 4.00 2.00
Thrombosis 0 0.14 0.47 0.53 0.40
Hemorrhage 0.50 1.34 1.92 0.53 1.90
Totals 1.50 3.34 4.44 5.07 4.30

 

Comparison On-X Morbid Event Rates – On-X Aortic vs. Tissue Aortic (% per pt-year)

Event On-X1 N=184(2.8) 514** SJM2 N=577 (2.0) 1325** CMI3 N=868 (1.4) 1241** ATS4 N=267 (9.1) 2335**
Structural Dysfunction 0 0 0 2.0
Valve-Related Death 0.2 0.5 1.3 1.6
Thromboembolism 1.0 1.5 2.1 1.6
Totals 1.8 2.3 4.0 5.6

** Number of patients (average follow-up years) total patient years
 

References

  1. Summary of Safety and Effectiveness, On-X® Prosthetic Heart Valve, Food and Drug Administration PMA P000037, May 30, 2001; P000037/S1 March 6, 2002; Primary European Trial P000037/R2, May 31, 2003.
  2. Weighted averages calculated from references listed in the On-X Experience, Volume 2, Issue 1, Sept. 2000. (PDF)
  3. Summary of Safety and Effectiveness, Carbomedics® Prosthetic Heart Valve, Food and Drug Administration PMA P900060, September 29, 1993.
  4. Summary of Safety and Effectiveness, ATS Open Pivot® Bileaflet Heart Valve, Food and Drug Administration PMA P990046, October 13, 2000.
  5. Summary of Safety and Effectiveness, St. Jude Medical Toronto SPV® Valve, Food and Drug Administration PMA P970030, November 26, 1997.
  6. Summary of Safety and Effectiveness, Medtronic Freestyle® Aortic Root Bioprosthesis, Food and Drug Administration PMA P970031, November 24, 1997.
  7. Frater et al., Long-term durability and patient functional status for the Carpentier-Edwards Perimount pericardial bioprosthesis in the aortic position, J Heart Valve Dis 1998;7:48-53.
  8. Birnbaum D., Laczkovics A, Heidt M, Oelert H, Laufer G, Greve H, Pomar JL, Mohr F, Haverich A, Regensburger D., Examination of hemolytic potential with the On-X® prosthetic heart valve. J Heart Valve Dis. 2000; 9(1):142-5.

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