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Tyco Healthcare Release: INDERMIL(R) Tissue Adhesive Receives FDA Approval As A Microbial Barrier


10/19/2005 5:09:44 PM

NORWALK, Conn., Jan. 20 /PRNewswire/ -- The Syneture division of United States Surgical, a business unit of Tyco Healthcare, announced today that it received U.S. Food and Drug Administration (FDA) approval to market INDERMIL(R) (n-Butyl-2-Cyanoacrylate) Tissue Adhesive with the additional claim that it acts as a barrier to microbial penetration as long as the adhesive film remains intact. INDERMIL(R) is indicated for the closure of topical skin incisions and lacerations. It sets into a thin film over wound edges to seal out common forms of bacteria that may cause infection. INDERMIL(R) Tissue Adhesive was developed and is manufactured by Henkel Corporation through its subsidiary Henkel Loctite (Ireland) Ltd. in Dublin, Ireland, and is distributed by Syneture.

"I use INDERMIL(R) Tissue Adhesive in the closing of my median sternotomies, saphenous vein harvest sites, and whenever I put in a Pacemaker to essentially seal the wound," says Dr. Bradley Taylor, Chief of Cardiovascular Surgery, University of Pittsburgh Medical Center Passavant Hospital. "Patients are happy and pleased with how their incisions look and, more importantly, I found that the little breaks that usually cause superficial wound infections haven't been occurring since I began using INDERMIL(R) as a wound dressing to protect the wound."

In addition, the Syneture division has received FDA approval to market the Kendall Monoject Bluntip(TM) I.V. Access Cannula as an INDERMIL(R) Tissue Adhesive accessory product. The cannula may be affixed to the ampule tip to provide greater visibility when applying INDERMIL(R) Tissue Adhesive by positioning the physician's hand, which is lightly squeezing the ampule above the wound, making the wound easier to see. The cannula also requires over 25% less force to dispense 10 drops of the product through its smaller opening, facilitating the application of INDERMIL(R) Tissue Adhesive sparingly and meticulously in a single application. INDERMIL(R) plus the cannula tip accessory maintains its non-clogging feature, which maximizes wound coverage per vial and the cost-effectiveness of this new technology for wound closure and as a wound dressing.

"I find the accessory cannula tip ideal for closing pediatric lacerations because I can visualize the wound better and control the flow of INDERMIL(R) Tissue Adhesive with pin-point accuracy around the eye and hard to access areas of the ear," says Dr. Douglas Walsh, Pediatric ER Physician, St. Vincent's Hospital, Indianapolis, IN. "INDERMIL(R) Tissue Adhesive's ready-to- use formula and non-clogging tip may be applied, stopped, and restarted at any time, allowing me to dictate the application of material without racing the clock. In addition, its single application and 30-second set time means less time coaxing my pediatric patients to remain still."

About Syneture

The Syneture division of United States Surgical is the evolution of United States Surgical/Davis & Geck from a product-driven suture company to an organization focused on clinical solutions to wound closure with advanced suture and biosurgery therapies. The Syneture division manufactures and markets a comprehensive line of high quality sutures and biosurgery products. It is dedicated to being the healthcare professional's partner-of-choice and to advancing suture technology and biomaterials that improve patient outcomes. For more information about Syneture, please visit http://www.syneture.com/.

About Tyco Healthcare

Tyco Healthcare, a major business segment of Tyco International Ltd., is a leading manufacturer, distributor and servicer of medical devices worldwide. Its broad portfolio includes disposable medical supplies, monitoring equipment, medical instruments and bulk analgesic pharmaceuticals, sold under such names as Auto Suture, Kendall, Mallinckrodt, Nellcor, Puritan Bennett, Syneture, and Valleylab.

About Henkel

With brands and advanced technologies, Henkel makes people's lives easier, better and more beautiful. The Loctite Biomedical Group is a division of Henkel Technologies, a market leader in adhesives, sealants and surface treatments. Henkel Technologies serves the industrial, automotive, electronics, medical, biomedical and aerospace industries. The Henkel Group, headquartered in Düsseldorf, Germany, operates in three strategic business areas -- Home Care, Personal Care, and Adhesives, Sealants and Surface Treatments. INDERMIL(R) is a trademark of Henkel Loctite Corporation.

Further information about INDERMIL(R) For more information about INDERMIL(R) Tissue Adhesive please contact your local Syneture Sales Representative or contact the U.S. Surgical Customer Service Department: Phone: 1-800-722-8772; Fax: 1-800-544-8772, or visit our website: http://www.syneture.com/.

Tyco Healthcare

CONTACT: Cynthia M. Holloway of Syneture, +1-203-845-1966,cynthia.holloway@tycohealthcare.com; or Amy Saras of Tyco Healthcare,+1-508-261-8027, amy.saras@tycohealthcare.com



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