This is a novel, patented technology whereby the surface of each fibre within a macroporous polyester matrix is totally covered by fluoropolymer molecules.
An interpenetrating polymer network ensures that the fluoropolymer is tightly bonded to each fibre.
This is a novel, patented technology1, 2, whereby the surface of each fibre within a macroporous polyester matrix is totally covered by fluoropolymer molecules. The process ensures that the fluoropolymer molecules bond with the polyester giving an interpenetrating molecular network at the interface between the two polymers.
The thinness of the covering (less than 10 nanometres) does not allow it to be seen using mainstream technology - this can, however, be achieved by using Secondary Ion Mass Spectroscopy (SIMS). The output from the SIMS instrument visualises the presence of fluorine atoms over the total surface, providing evidence of a completely fluoropassivated structure.
The result is a new biomaterial, a novel fluoropolymer. In vitro, in vivo and ex vivo studies on platelet deposition confirm that the Fluoropassiv™ biomaterial exhibits significantly reduced thrombogenicity compared to polyester and ePTFE3, 4, 5. Improved healing is evidenced in animal models by more complete pseudointimal development and vasa vasorum6,7 formation. A thin pseudointima has been noted with extensive coverage by endothelium even in the mid portion of long thoracoabdominal grafts7. Fluoropassivation is used in the production of Thin Wall peripheral grafts and carotid patches.
No clinical data is available which evaluates the long-term impact of the fluoropassivated surface modification treatment. (Claims based on animal and laboratory data available from Vascutek Ltd).
Fluoropassivated carotid patches received FDA clearance in April 1998. Available in USA from 1st April 1999.
Advantages of Fluoropassivation
|Gloviczki's Group, Mayo Clinic, Rochester,
Minnesota USA4 (carotid patch model)
|Hanson's Group, Emory University School
of Medicine, Atlanta, Goergia, USA5
(ex vivo arteriovenous shunt model)
1. U.S. Patent No. 5,356,668
2. European Patent No. EP 0560849 B1
3. Ashton T. et al.
Platelet Thrombogenic Response to Polyester can be Passivated by Fluoropolymer surface Treatment.
European Society for Biomaterials, (1995)
4. Rhee R. et al.
Experimental Evaluation of Bleeding Complications, Thrombogenicity, and Neonintimal Characteristics of Prosthetic Patch Materials used for Carotid Angioplasty.
Cardiovascular Surgery, (1996). Vol.4, No.6, 746-752
5. Chinn J.A. et al.
Blood & Tissue Compatibility of Modified Polyester: Thrombosis, Inflammation and Healing.
Journal for Biomedical Materials Research. (1998), Vol. 39, 130-140
6. Curti T. et al.
Biocompatibility of the New Fluoropassiv™ Vascular Prosthesis- Ultrastructure Analysis.
Giornale Italiano di Chirurgia Vascolare (1994), Vol.1, No.1-2, 27-30
7. Guidon R. et al.
The Benefits of Fluoropassivation of Polyester Arterial Prosthesis as Observed in a Canine Model.
American Society for Artificial Internal Organs, (1994), Vol 40, No. 3, M870-879
All clinical papers are available upon request.