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New Data Demonstrate Magnetic Resonance Safety of AQUACEL(R) Ag Dressing
Date:8/24/2009

SKILLMAN, N.J., Aug. 24 /PRNewswire/ -- ConvaTec, a world-leading provider of innovative medical technologies for community and hospital care, today announced new data showing that AQUACEL(R) Ag, the company's advanced antimicrobial dressing, is safe for use in an MRI environment.

AQUACEL(R) Ag dressing was developed to provide clinicians and patients with all the unique gelling benefits of ConvaTec's proprietary Hydrofiber(R) Technology plus the benefits of ionic silver. This gelling action enables the dressing to lock in exudate and its harmful components(2-4a) and contour closely to the wound bed.(5a) With the addition of ionic silver, AQUACEL(R) Ag dressing provides broad-spectrum antimicrobial activity "on demand," responding to increased bacterial load with increased silver ion availability while killing a broad range of pathogens in the dressing, including MRSA and vancomycin-resistant enterococci (VRE).(6,7a,b)

The new research, published in the Journal of the American College of Radiology, demonstrated that AQUACEL(R) Ag may be classified as MR safe as defined in the American Society for Testing and Materials (ASTM) standard F2503-05.(1) An independent agency review, funded by ConvaTec, also demonstrated the safety and compatibility of the dressing in an MRI environment (up to 3 Tesla 128 MHz, SAR up to 2 W/kg), according to the standards of the ASTM.(8)

"ConvaTec initiated this important research because many of our customers have patients, particularly those in orthopaedic or burns units, who may need MRI scanning," said Marcus Schabacker, Chief Scientific Officer of ConvaTec. "With these findings, clinicians can be confident that AQUACEL(R) Ag is safe for use in this environment, and they will no longer need to remove and reapply the dressing before and after entering the MRI machine."

(a.) As demonstrated in vitro.

(b.) The amount of silver released is controlled by the maximum concentration of silver that can enter solution.

Advanced Wound Dressings with Hydrofiber(R) Technology from ConvaTec

ConvaTec dressings with Hydrofiber(R) Technology gel on contact with fluid, providing clinicians and patients with substantial wound care benefits. This transformational technology, unique to ConvaTec, powers the performance of advanced wound care products, including AQUACEL(R), AQUACEL(R) Ag, and Versiva(R) XC(R) dressings, each developed for different wound management needs.

AQUACEL(R) and AQUACEL(R) Ag dressings are soft, absorbent non-woven wound dressings based on Hydrofiber(R) Technology. Indicated for a wide range of moderate-to-highly exuding chronic and acute wounds, AQUACEL(R) and AQUACEL(R) Ag dressings come in a variety of shapes, sizes and formats. AQUACEL(R) Ag dressing also is indicated for the management of infected wounds and wounds at risk of infection.

Versiva(R) XC(R) dressing provides all the benefits of Hydrofiber(R) Technology plus a waterproof backing that acts as a barrier against bacteria and viral pathogens, including HIV and Hepatitis.(c,d) The unique properties of Versiva(R) XC(R) dressing help progress wounds toward healing.(9,10) Indicated for use with moderately-to-highly exuding chronic and acute wounds, because it includes Hydrofiber(R) Technology, Versiva(R) XC(R) dressing is also the only dressing designed specifically to cover AQUACEL(R) and AQUACEL(R) Ag dressings.

ConvaTec dressings containing Hydrofiber(R) Technology have been evaluated in numerous clinical trials across a range of chronic and acute wounds, including pressure ulcers, leg ulcers, diabetic foot ulcers, partial thickness (second degree) burns and surgical incisions.

About ConvaTec

ConvaTec is a leading developer and marketer of innovative medical technologies that have helped improve the lives of millions of people worldwide. With four key business divisions - Ostomy Care, Wound Therapeutics, Continence and Critical Care and Infusion Devices - ConvaTec products support health care professionals from the hospital to the community health setting. From its headquarters in Skillman, New Jersey, the company oversees more than 8,000 employees in over 90 countries serving consumers and their health care professionals on six continents. For more information, please visit www.convatec.com.

(c.) Provided the dressing remains intact and without leakage. The use of this dressing neither guarantees nor warrantees against AIDS or Hepatitis virus transmission.

(d.) Use waterproof tape to secure the edges of non-adhesive dressing or dressings that have been cut across the central area.

(1.) Nyenhuis J, Duan L. An evaluation of MRI safety and compatibility of a silver-impregnated antimicrobial wound dressing. J Am Coll Radiol. 2009;6:500-505.

(2.) Waring MJ, Parsons D. Physico-chemical characterisation of carboxymethylated spun cellulose fibres. Biomaterials. 2001;22:903-912.

(3.) Walker M, Hobot JA, Newman GR, Bowler PG. Scanning electron microscopic examination of bacterial immobilisation in a carboxymethylcellulose (AQUACEL) and alginate dressing. Biomaterials. 2003;24(5):883-890.

(4.) Walker M, Bowler PG, Cochrane CA. In vitro studies to show sequestration of matrix metalloproteinases by silver-containing wound care products. Ostomy Wound Manage. 2007;53(9):18-25.

(5.) Jones SA, Bowler PG, Walker M. Antimicrobial activity of silver-containing dressings is influenced by dressing conformability with a wound surface. Wounds. 2005;17(9):263-270.

(6.) Jones SA, Bowler PG, Walker M, Parsons D. Controlling wound bioburden with a novel silver-containing Hydrofiber(R) dressing. Wound Repair Regen. 2004;12(3):288-294.

(7.) Bowler PG, Jones SA, Walker M, Parsons D. Microbicidal properties of a silver-containing Hydrofiber(R) dressing against a variety of burn wound pathogens. J Burn Care Rehabil. 2004;25(2):192-196.

(8.) SwRI(R) Biomedical Engineering. MR Safety of the AQUACEL(R) Ag Dressing. 14059-0029 Rev 3. May 20, 2009. Data on file. ConvaTec.

(9.) Vanscheidt W, Munter KC, Klovekorn W Vin F, Gauthier JP, Ukat A . A prospective study on the use of a non-adhesive gelling foam dressing on exuding leg ulcers. J Wound Care. 2007;16(6):261-265.

(10.) Parish LC, Dryski M, Cadden S. Prospective clinical study of a new adhesive gelling foam dressing in pressure ulcers Int Wound J. 2008;5:60-67.

Hydrofiber, AQUACEL, Versiva, and Versiva XC are registered trademarks of ConvaTec Inc.

(C) 2009 ConvaTec Inc.

AP-008172-US

    Contacts

    Punnie Donohue
    ConvaTec
    Phone: (908) 904-2151
    Punnie.Donohue@convatec.com

    Courtney Judd
    Weber Shandwick
    Phone: (212) 445-8365
    cjudd@webershandwick.com


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