OnXLTI Heart Valve product group - prosthetic hearts valves that rival tissues valves
OnXLTI company information
prosthetic heart valves
OnXLTI Cardiac Surgery product group
OnXLTI Contract Manufacturing product group
FDA Clinical Results

On-X Life Technologies, Inc. (On-X LTI) was formerly
Medical Carbon Research Institute (MCRI).

FDA Clinical Results

The Federal Food and Drug Administration approved the On-X aortic and mitral valves for use in the United States on May 30, 2001 and March 6, 2002 respectively. To view the FDA summaries of safety and effectiveness in .pdf format, click on the following links:

» Summary of Safety and Effectivity: On-X Aortic Valve

» Summary of Safety and Effectivity: On-X Mitral Valve


Hemolysis

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

Upper normal = 250
Valve 3-6 mo. 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 0.00 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 of 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 0.0 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
* Combined subcoronary, full root and root inclusion.
** 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.

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.