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Ethicon receives FDA clearance to market first ever antibacterial suture
New Jersey | Monday, December 23, 2002, 08:00 Hrs  [IST]

Ethicon Products, a division of Ethicon Inc, a Johnson & Johnson company, has received U.S. Food and Drug Administration (FDA) clearance to market Vicryl Plus Antibacterial Suture. Designed to reduce bacterial colonization on the suture, Vicryl Plus is the first and only suture designed with an antibacterial agent. The agent is known to be effective against staphylococcus aureus, staphylococcus epidermidis and methicillin resistant strains of staphylococcus (MSRA and MRSE), the leading surgical site bacteria.

During the last 20 years, hospital acquired infections have increased by 36 percent, costing the United States more than $2 billion annually,and surgical site infections (SSIs) are a serious concern for the 27 million surgical patients each year. According to the Centers for Disease Control and Prevention, 2-3% of surgeries result in SSIs. That translates to 675,000 occurrences of surgical site infections annually.

Vicryl Plus marks the first time a coated suture for wound closure has been introduced. It begins to work the moment it comes into contact with the patient by creating an "Active Zone" around the suture.

"When I prepare for surgery, I take every precaution, such as scrubbing my hands and wearing gloves to protect my patient against bacterial contamination," said Philip S. Barie, Associate Professor of Surgery, Medical College of Cornell University. "With the clearance of Vicryl Plus, I now have another tool to add to my routine to help protect patients. This device represents a major improvement in suture technology that holds the promise of making surgery safer for all patients who undergo surgery, as it is the first device ever to inhibit bacterial colonization of the suture."

Because the suture is absorbable, it should not be used where extended approximation of tissue under stress is required. The suture should not be used in patients with known allergic reactions to Irgacare MP (Triclosan). Refer to Instructions for Use for complete information on Vicryl Plus.

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