|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
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|
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)|
|On-X Morbid Event Rates Comparison – Mitral Position (% per pt-year)|
|Comparison On-X Morbid Event Rates – On-X Aortic vs. Tissue Aortic (% per pt-year)|
|* Combined subcoronary, full root and root inclusion.
** Number of patients (average follow-up years) total patient years.
- 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.
- Weighted averages calculated from references listed in the On-X Experience, Volume 2, Issue 1, Sept. 2000. (PDF)
- Summary of Safety and Effectiveness, Carbomedics® Prosthetic Heart Valve, Food and Drug Administration PMA P900060, September 29, 1993.
- Summary of Safety and Effectiveness, ATS Open Pivot® Bileaflet Heart Valve, Food and Drug Administration PMA P990046, October 13, 2000.
- Summary of Safety and Effectiveness, St. Jude Medical Toronto SPV® Valve, Food and Drug Administration PMA P970030, November 26, 1997.
- Summary of Safety and Effectiveness, Medtronic Freestyle® Aortic Root Bioprosthesis, Food and Drug Administration PMA P970031, November 24, 1997.
- 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.
- 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.