• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

INSERTING and REPLACING GORE DUALMESH(R) PLUS Biomaterial Inhibits Implant Infections By Drug-Resistant 'Superbugs' and Resists Biofilm Development

Posted on: Wednesday, 14 February 2007, 12:02 CST

Insert after 11th graph: GORE, CORDUROY®, DUALMESH®, DUALMESH® PLUS, and design are trademarks of W. L. Gore & Associates.

The corrected release reads:

GORE DUALMESH® PLUS BIOMATERIAL INHIBITS IMPLANT INFECTIONS BY DRUG-RESISTANT 'SUPERBUGS' AND RESISTS BIOFILM DEVELOPMENT

W. L. Gore & Associates (Gore) today announced that laboratory results show GORE DUALMESH® PLUS Biomaterial is the only hernia repair material inhibiting bacterial colonization of the device for up to 14 days post-implantation and the only prosthetic patch resisting initial biofilm formation over the same period of time.

Gore's antimicrobial technology provides effective inhibition of bacterial colonization of prosthetic biomedical implants by 10 different strains of gram-positive and gram-negative bacteria, comprised of laboratory and clinical isolates, including drug-resistant "superbugs" such as Methicillin-resistant Staphylococcus aureus (MRSA) and Vancomycin-resistance Enterococcus Faecalis (VRE).

GORE DUALMESH® PLUS Biomaterial is the only two-sided, prosthetic patch loaded with the antimicrobial agents silver and chlorhexidine indicated for the reconstruction of hernias and soft tissue deficiencies. Silver and chlorhexidine act synergistically to inhibit microbial colonization of the device post-implantation by permeating bacterial cell walls and binding bacterial cell proteins.

Results demonstrating extended inhibition of bacterial colonization and resistance to initial biofilm formation for GORE DUALMESH® PLUS Biomaterial was cleared by the U.S. Food & Drug Administration (FDA) in November 2006 and European Union (EU) clearance is pending.

"Surgical site infections (SSIs) are the second most commonly reported hospital acquired infection and can lead to increased rates of morbidity and mortality," said Bill Barrett, Ph.D., Gore Product Specialist. "Bacteria are introduced primarily at the time of device implantation or in the immediate post-operative period. When bacteria adhere to the device, they can produce their own protective biofilm which is difficult to detect and treat."

Biofilms have been implicated in the spread of antibiotic resistance and colonization of medical devices. Multidrug-resistant organisms such as MRSA are causing an increasing number of SSIs in the United States, with damaging effects. One study reported that patients with an MRSA SSI spent an additional five days in the hospital with a mortality rate of 20.7%.1

Consequences of SSIs often include increased patient pain and discomfort, longer hospital stays, and possible additional surgery to remove an infected device. These consequences invariably lead to increased healthcare costs.

GORE DUALMESH® PLUS Biomaterial loaded with antimicrobials is comprised of Gore expanded polytetrafluoroethylene (ePTFE), which has a 20-year history of supple, strong, and safe abdominal wall repair in the intraperitoneal position. The material is engineered to have two functionally distinct surfaces; the textured CORDUROY® surface encourages rapid host tissue incorporation, while the smooth surface is designed to minimize visceral and intra-abdominal tissue attachment.

1 Engemann, JJ, Carmeli, Y, Cosgrove SE, Fowler VG, Bronstein MZ, Trivette SL, et al., Adverse clinical and economic outcomes attributed to methicillin resistance among patients with Staphylococcus aureus surgical site infection. Clin Infect Dis 2003; 36:592-598.

ABOUT W. L. GORE & ASSOCIATES, INC.

The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, Gore has implanted more than 23 million innovative medical devices, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical patches and meshes for hernia repair, and sutures for use in vascular, cardiac, general surgery and orthopedic procedures. Gore was recently named the tenth best company to work for in the United States by Fortune Magazine.

Products listed may not be available in all markets pending regulatory clearance.

GORE, CORDUROY®, DUALMESH®, DUALMESH® PLUS, and design are trademarks of W. L. Gore & Associates.

Visit http://www.indsource.com/wlgpr/wlg_dmp.tif.zip to download a hi-res image.

Source: Business Wire

More News in this Category