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Sealant Technology

Vascutek sealed products feature a unique patented modified bovine gelatin impregnation with over 15 years of clinical experience worldwide. These products are 100% porosity tested by Vascutek.

Gelatin modification controls chemical crosslink density

The impregnation also demonstrates a number of other significant features, in addition to its primary function as a sealant. Unlike other sealants, it hydrolyses over a period of 14 days by a non-enzymatic mechanism that does not elicit a prolonged inflammatory response2. This degradation profile allows unimpaired tissue incorporation into the matrix of the graft3,4.

Added Benefits of Gelatin Sealant Technology

Low Thrombogenicity / Heparin Bonding*

Gelatin has been shown to have a low thrombogenicity4,5. Under test conditions, sealed polyester attracts fewer platelets than non-impregnated polyester 6 and collagen sealed polyester7. It also passively absorbs heparin* (achieved with a simple soaking technique) providing short-term high local concentration at the surface of the material. This gives additional active thromboresistance during the critical post-operative period that is particularly useful in low flow situations8.

Heparin bonding to Vascutek unique gelatin has CE dossier approval15

Antibiotic Bonding*

Vascutek gelatin has been shown to be the ideal sealant for ionically bonding to the antibiotic Rifampicin*9. This technique maybe used in order to minimise the incidence of postoperative graft infection10. The simple bonding procedure is particularly useful in high-risk cases10,11, including the replacement of infected grafts12, where the rifampicin-gelatin combination will survive arterial pressure and flow13. Vascutek Rifampicin* bonded grafts have been shown to be significantly more resistant to bacteremic infection than silver/collagen coated grafts14.

Rifampicin* bonding to Vascutek unique gelatin has CE dossier approval15 and is backed by over 35 publications and 10 years experience. Publications on request.

Note: * These applications of Heparin and Rifampicin have not been approved by the FDA for use in the USA or by TPD for use in Canada

References (Click to expand)

1. US Patent No: 4,747,848

2. Vohra R, et al.
Sealed Versus Unsealed Knitted Dacron® Prosthesis: A Comparison of the Acute Phase Protein Response.
Annals of Vasc Surg. (1987) I: 548-551

3. Jonas R A, et al.
Unsatisfactory Clinical Experience with a Collagen-Sealed Knitted Dacron® Extracardiac Conduit.
Journal of Cardiac Surgery. (1987), Vol 2, No 2, 257-264

4. Harasaki H. et al.
Blood-Blood Pump Surface Interaction.
Ch 9 Biocompatible Polymers, Metals and Composites, ed. M. Szycher, Technomic (1983)

5. Gloviczki P. et al.
Experimental Evaluation of Bleeding Complications, Thrombogenicity and Neointimal Characteristics of Prosthetic Patch Materials Used for Carotid Angioplasty.
Cardiovascular Surgery (1996), Vol. 4, No 6, 746-752

6. Drury J.K. et al.
Experimental and Clinical Experience with a Gelatin Impregnated Dacron® Prosthesis.
Ann. Vasc Surg (1987);5; 542-547

7. Safepharm Report on Thrombogenicity (Data available on request)

8. Data on file at Vascutek Ltd.

9. Ashton T. et al.
Antibiotic Loading of Vascular Grafts
16th Annual Meeting of the Society for Biomaterials, May 1990, Charleston, USA

10. Strachan C.J.L. et al.
The Clinical Use of an Antibiotic-Bonded Graft.
Eur J Vasc Surg (1991), 5, 627-632

11. Strachan C.J.L. et al.
Prosthetic Graft Infection.
Critical Ischaemia (1993), Vol 2. No 3, 5-16

12. Naylor A R et al.
Treatment of Major Aortic Graft Infection: Preliminary Experience with Total Graft Excision and In Situ Replacement with a Rifampicin Bonded Prosthesis.
Eur J Vasc Endovasc Surg. (1995), 9, 252-256

13. Braithwaite B.D. et al.
Early Results of a Randomized Trial of Rifampicin-Bonded Dacron Grafts for Extra-Anataomic Vascular Reconstruction

British Journal of Surgery 1998; 85; 1378-1381

14. Goëau-Brissonnière, Olivier et al.
Comparison of the Resistance to Infection of Rifampicin Bonded Gelatin-Sealed and Silver/Collagen-Coated Polyester Prostheses.

Journal of Vascular Surgery 2002; vol 35, No 6; 1260-1263

15. Rinsing of Gelatin Sealed Prostheses with Rifampicin and/or Heparin BSI EQ# 10020927

All clinical papers are available upon request.

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