ALCapshaw2
Well-known member
A few years ago, On-X sent me an 'Information Package' which included a pair of tables entitled "Morbid Event Rates Comparison" for both the Aortic and Mitral positions with footnotes indicating the source of the data for each company which included PMA (something about Safety and Effectiveness) Summaries (ATS and CMI) and FDA submissions.
The combined rates in (% per pt-year) for Thromboembolism, Thrombosis, and Hemorrhage for the
Aortic Position were
On-X = 2.14 % per pt-year
SJM = 3.90 St. Jude Medical
CMI = 2.96 Carbomedics
ATS = 4.04 ATS
MH = 2.50 Medtronic Hall (I believe that is a single leaflet valve)
Mitral Position
On-X = 1.86 % per pt-year
SJM = 3.34
CMI = 4.44
ATS = 5.07
MH = 4.30
I left off the breakdowns by categories because I'm not about to sit here and re-type all that data. Note that other factors such as Hemolysis (blood cell damage) and Pannus Tissue Growth are not included in the above statistics.
The complete charts are available to ANYONE who asks for them. Just call or e-mail On-X and they will send you whatever information you request. Contact information is on their website www.onxvalves.com or 888-339-8000.
They have recently published another set of Bar Graphs which also include several tissue valves (which I find a little hard to interpret - too much information in too little space... give me the numbers in a spread sheet format please).
'AL Capshaw'
The combined rates in (% per pt-year) for Thromboembolism, Thrombosis, and Hemorrhage for the
Aortic Position were
On-X = 2.14 % per pt-year
SJM = 3.90 St. Jude Medical
CMI = 2.96 Carbomedics
ATS = 4.04 ATS
MH = 2.50 Medtronic Hall (I believe that is a single leaflet valve)
Mitral Position
On-X = 1.86 % per pt-year
SJM = 3.34
CMI = 4.44
ATS = 5.07
MH = 4.30
I left off the breakdowns by categories because I'm not about to sit here and re-type all that data. Note that other factors such as Hemolysis (blood cell damage) and Pannus Tissue Growth are not included in the above statistics.
The complete charts are available to ANYONE who asks for them. Just call or e-mail On-X and they will send you whatever information you request. Contact information is on their website www.onxvalves.com or 888-339-8000.
They have recently published another set of Bar Graphs which also include several tissue valves (which I find a little hard to interpret - too much information in too little space... give me the numbers in a spread sheet format please).
'AL Capshaw'