Technology

Sealant Technology

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

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 response^2,3. This degradation profile allows unimpaired tissue incorporation into the matrix of the graft ⁴.

Low Thrombogenicity / Heparin Bonding*

Gelatin has been shown to have a low thrombogenicity^4,5. 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 cases^10,11, 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

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.
J Cardiac Surg. (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. Vascular Surgery (1987), 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.
J Vasc Surg 2002; 35; 1260-1263

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