CE Mark For INTERGARD SYNERGY Vascular Graft
MAQUET Cardiovascular, LLC announced today that it has received CE mark for its INTERGARD SYNERGY vascular graft. This graft represents the next generation in antimicrobial grafts combining the well-known antimicrobial properties of silver acetate and triclosan. The INTERGARD SYNERGY graft will be commercially available immediately within countries that recognize the CE mark.
Vascular graft infection, although rare, is one of the most serious complications of vascular reconstructive surgery. Conservative treatment of prosthetic graft infections is rarely successful and is used only in patients with a high operative risk or apparently limited infection. Therefore, the most effective strategy against this severe complication is primary prevention of vascular graft infection. "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 prosthesis 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."
The INTERGARD SYNERGY graft is designed to help prevent infection by using 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, their power to prevent development of infection is intensified when combined and offers surgeons a vascular graft with increased antimicrobial properties. In vitro testing of the INTERGARD SYNERGY vascular graft demonstrates antimicrobial efficacy against a broad spectrum of micro-organisms including MRSA (Methicillin Resistant Staphylococcus Aureus) and is substantially more effective than the first generation INTERGARD SILVER graft -.
"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 MAQUET Cardiovascular. "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."
MAQUET has unparalleled experience in helping to prevent vascular infection having received the CE mark and launch of its first generation antimicrobial INTERGARD SILVER graft in 1999. INTERGARD SILVER was the world's first antimicrobial vascular prosthesis when launched and since that time over 180,000 of this first generation antimicrobial grafts have been implanted in patients with excellent results.