CE Mark For Maquet’s Intergard Synergy Antimicrobial Vascular Graft

In short

Medical Device manufacturer Maquet Cardiovascular, LLC has announced that it has gained CE mark for its Intergard Synergy vascular graft. The company reckons its graft represents the next generation in antimicrobial grafts combining the well-known antimicrobial properties of silver acetate and triclosan.

Background

Vascular graft infection, although rare at between 1 and 6% in the literature(3), is one of the most serious complications of vascular reconstructive surgery and almost never results in conservative treatment. Maquet judges therefore, that by preventing vascular graft infection it must be onto a winner. Indeed its new graft builds on the earlier generation world first Intergard Silver graft which dates back as far as 1999, and is claimed to be substantially more effective in in vitro testing against a broad spectrum of microorganisms including MRSA(1,2), widely reported as the most common source of post-operative infection in vascular surgery patients.

The Intergard Synergy graft employs a combination of the broad spectrum anti-infective properties of silver and triclosan, which are released from the surface of the graft to surrounding tissues following implantation.

While silver acetate and triclosan are effective antimicrobial agents alone, Maquet’s data suggests that their power to prevent development of infection is intensified when combined(1).

 Clinician comments

“This new Intergard Synergy uses an interesting approach to fight against acquired infection in vascular surgery patients. The combination of these two well-known and effective antimicrobial agents on the vascular graft is promising. This new infection protection holds the potential to enhance my ability to ensure that my vascular surgery patients remain infection free,” stated Max Zegelman, M.D., Ph.D. of Krankenhaus Nordwest, Frankfurt, Germany. “I have long been an advocate of antimicrobial coatings on surgical prostheses even though there is not yet evidence-based demonstration of their impact on overall infection rates. I believe Intergard Synergy graft is offering new possibilities.”

Company comments

“The Intergard Synergy graft is another example of Maquet Cardiovascular’s commitment to providing customers with new and innovative solutions that improve patient care for years to come,” said Christian Keller, President and CEO of the company. “Maquet’s innovative spirit has allowed us to pioneer the development of vascular graft prostheses with antimicrobial properties and bring the Intergard Synergy graft to market.”

We say

We’re curious. Anti-infective treated prostheses have never really taken off, and we’re wondering why not. So let’s speculate. Firstly we’re expecting treated grafts are more expensive than their plain vanilla rivals. If so it is therefore a simple question of doing the maths to establish whether what Maquet admits is a small risk of graft infection is worth the expense of using the device routinely.

And then there’s the clinical evidence. Or rather there isn’t, because a study population large enough to pick up a statistically significant reduction in infection rate would be massive, so we’re left with in vitro work and a simple decision for the clinician. Dr Zegelman, quoted above, likes the concept enough to see past the lack of evidence, so maybe Maquet is onto something.

Source: Maquet, PR Newswire

(1) Data on file, Maquet

(2) In vitro evaluation of the antimicrobial efficacy of a new silver-triclosan vs a silver collagen-coated polyester vascular graft against methicillin-resistant Staphylococcus aureus. Ricco JB, Assadian A, Schneider F, Assadian O. J Vasc Surg. 2012 Mar;55(3):823-9. Epub 2011 Nov 10.

(3) Prosthetic Vascular Graft Infection: A Multi-Center Review of Surgical Management. Eleonore Zetrenne, MD, Bryan C. McIntosh, MD, Mark H. McRae, BA, Richard Gusberg, MD, Gregory R.D. Evans, MD, FACS, and Deepak Narayan, MS, FRCS, Yale J Biol Med. 2007 September; 80(3): 113–121.