|
Freestyle® Aortic Root Bioprosthesis
Physiologic Fixation™ Process
Similarity to Native Tissue
Leaflets fixed under even very low pressure can exhibit alteration of fibrosal corrugations and collagen crimp. This stiffens the leaflets, resulting in a decreased radial and circumferential compliance, which may be disadvantageous to the functional performance of the valve.
Fresh Aortic Valve Leaflet
|
 |
Physiologic Fixation |
 |
|
 |
Cross-section of fresh porcine aortic leaflet shows the distinction between the fibrosa, the spongiosa, and the ventricularis layers. |
|
Cross-section of porcine valve leaflet showing morphology almost identical to the fresh leaflet with thickness and three-layered structure preserved. |
Biaxial testing confirms that root-pressure fixation with valve leaflets at zero-pressure differential (the process used for Physiologic Fixation) is more advantageous to the functional performance of the valve. [Christie, Vesely, Mayne]
Biaxial Radial Comparison |
|
Biaxial testing demonstrates root-pressure fixed valves have leaflets that exhibit mechanical properties much like fresh tissue. [Christie, Mayne] |
*No clinical data are available that evaluate the long-term impact of the Physiologic Fixation process in patients.
|
