ETHICON Receives FDA Clearance to Market VICRYL Plus, First-Ever Antibacterial Suture

SOMERVILLE, N.J. -- Representing a new era of devices that may help reduce the risk of complications associated with surgery, ETHICON Products, a division of ETHICON, INC., a Johnson & Johnson company, announced today that it 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) (1-2), the leading surgical site bacteria.

During the last 20 years, hospital acquired infections have increased by 36 percent (3), costing the United States more than $2 billion annually, (4-6) and surgical site infections (SSIs) are a serious concern for the 27 million surgical patients each year.(7) According to the Centers for Disease Control and Prevention, 2-3 percent of surgeries result in SSIs.(8) That translates to 675,000 occurrences of surgical site infections annually.(9)

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, MD, associate professor of surgery at 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).

ETHICON Products, a division of ETHICON, INC., a Johnson & Johnson company, continues Johnson & Johnson's 100-year commitment to wound care today with inventive products for wound closure and cardiovascular surgery. ETHICON Products is the worldwide leader in suture products and suture technology, and is one of the most recognizable and well-respected brand names in the hospital environment. The division has a long history of innovation in providing products -- including sutures, topical adhesives, surgical meshes and wound drains -- that enhance patient care. Pioneering cardiovascular products include surgical devices that restore and improve the circulatory health and quality of life for people with cardiovascular disease.

References:

(1) Rothenburger S., Spangler D., Bhende S., Burkley D. In vitro

Antibacterial Evaluation of Coated VICRYL Plus Antibacterial Suture

Using Zone of Inhibition Assays; Surgical Infection Society (SIS)

Journal (suppl) Dec 02-In Press.

(2) Infection Control and Hospital Epidemiology: Guideline for Prevention

of Surgical Site Infection, 1999

(3) CDC: Emerging Infectious Disease, Nosocomial Infection Update,

Weinstein R.; Vol. 4, No. 3, July - September 1998

(4) Infection Control and Hospital Epidemiology: Guideline for Prevention

of Surgical Site Infection, 1999

(5) Gilbert P. Literature-Based Evaluation of the Potential Risks

Associated With Impregnation of Medical Devices and Implants with

Triclosan.; Surgical Infection Society (SIS) journal (suppl)

Dec 02-In Press.

(6) Fry D.E. The Economic Costs of Surgical Site Infection; Surgical

Infection Society (SIS) journal (suppl) Dec 02-In Press.

(7) Infection Control and Hospital Epidemiology: Guideline for Prevention

of Surgical Site Infection, 1999

(8) Infection Control and Hospital Epidemiology: Guideline for Prevention

of Surgical Site Infection, 1999

(9) Infection Control and Hospital Epidemiology: Guideline for Prevention

of Surgical Site Infection, 1999

Source: PRNewswire