MECHANICAL VALVES - History of the Modern Bi-Leaflet Designs

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ALCapshaw2

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Development History of the Bi-Leaflet Mechanical Valve Designs

Dr. Jack Bokros, Ph.D. has been involved in the design and development of All of the leading Bi-Leaflet Mechanical Valves starting with St. Jude, and followed by Carbomedics, ATS, and finally his latest (and greatest), the On-X Valves.

Here is an abbreviated History of the development and use of Pyrolytic Carbon in Mechanical Heart Valves taken from my copy of a Short Biography of Jack Bokros, Ph.D. who was involved in the development of the material for an application in the Nuclear Power Industry (NOT the Space Industry as is sometimes erroneously reported).
(Bolding below is mine)

1963
Discovery of isotropic pyrolytic carbon

1965
....... (confirmation that) pyrolytic carbon has favorable (blood contact) properties.....

1968
The first pyrolytic carbon heart valve component is produced at General Atomic Company (GAC) for the Debakey aortic heart valve and implanted in 1968.

1972
GAC produces the first carbon disk occluders to replace metallic and polymeric components. Pyrolite Carbon becomes the preferred material for occluders.

1976
St. Jude Medical, Inc. (SJM) approached GAC in 1976 to develop an all carbon heart valve replacement.
The carbon components for the first SJM valve implanted valve produced in 1977.

1979
Dr. Bokros formed Carbomedics (CMI) in Austin, Texas. Pyrolytic carbon components are produced for SJM, Duromedics-Edwards, Bjork-Shiley, Omniscience-Omnicarbon, Medtronic-Hall, Bicor and other valves.

1985
Dr. Bokros files patents that cover two pivot designs.
One has been employed in the original CarboMedics valve.
The other was licensed for use in the ATS Medical, Inc. valve.

1989
Carbon Implants, Inc. (Cii) is formed to improve carbon-processing technology.
A major advance in control of the pyrolytic process expands the potential of the process.
Dr. Bokros envisions the potential of the new carbon and the possibility for use in a generational advance in heart valve replacement.

1994
Medical Carbon Research Institute (MCRI) - the new carbon is named On-X carbon.
With the wisdom and experience of the MCRI team, Dr. Bokros designs the On-X Prosthetic Heart Valve
focusing primarily on the elimination of stasis and turbulence leading to reduction of blood trauma and clotting.

1996
The first implant of the On-X Valve.

2001
FDA approval of the On-X Aortic Valve is granted (for use in the USA).

2002
FDA approval of the On-X Mitral Valve is granted (for use in the USA)

2006
FDA approves first ever reduced anticoagulation study, PROACT, using the On-X Valves.
 
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