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Covidien Expands V-Loc(TM) Family of Absorbable Wound Closure Devices for Knotless Tissue Repair

Thu, 05/27/2010 - 2:41am
Covidien
Receives FDA 510(k) clearance to market the V-Loc(TM) 90 device

NORTH HAVEN, Conn., May 27, 2010 (BUSINESS WIRE) --Covidien (NYSE: COV), a leading global provider of healthcare products, today announced the global launch of the V-Loc(TM) 90 device, expanding its family of V-Loc(TM) absorbable wound closure devices. This latest addition to Covidien's knotless wound closure product line received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on May 11, 2010.

The V-Loc 90 device builds on the success of the V-Loc(TM) 180 device, launched in October 2009, as the first surgical device of its kind to feature uni-directional barbed technology. The device's unique and proprietary self-anchoring loop and barb combination enables surgeons to close dermal wounds quickly and securely without tying knots or changing standard closure techniques. Covidien V-Locdevices close wounds up to 50% faster than conventional sutures of comparable holding strength.*

The V-Loc 180 device holds the wound edges together securely for the critical wound healing period, with absorption substantially complete within 180 days. The V-Loc 90 device contains faster absorbing material, which is based on Covidien's Biosyn(TM) suture technology, and absorption is essentially complete within 90 to110 days. This makes the new device ideal for dermal and laparoscopic applications where a shorter absorption time is needed or preferred, such as in plastic reconstructive surgery, gynecologic surgery and general surgery.

"With this new addition to our knotless wound closure portfolio, surgeons have an even broader array of choices for closing surgical incisions safely, quickly and effectively," said Michel Therin, Vice President, Soft Tissue Repair & Biosurgery, Covidien. "The V-Loc 90 device is designed to provide better patient outcomes through the fast absorption of the product following the critical wound healing period after surgery."

Since the V-Loc device technology was first introduced, surgeons have used it in a wide variety of procedures for secure, fast and effective wound closure. Initial clinical testing shows that the use of V-Loc device technology significantly decreases the time needed to close surgical incisions.

"I have used the V-Loc 180 wound closure device for approximately one year in a wide variety of plastic reconstructive and aesthetic procedures and find it especially beneficial for closing long wounds," said Dr. Klaus J. Walgenbach, Plastic and Aesthetic Surgery, University Hospital Bonn. "The V-Loc device is easy to handle, and the tension it provides eliminates the need for a third hand. We also have experienced time savings during wound closure due to the elimination of knot implantation. The V-Loc device is a major step in wound closure."

The V-Loc 90 device will be presented at the European Association of Plastic Surgeons annual meeting in Manchester, U.K., May 27-29, 2010. It also was previewed at The American Society for Aesthetic Plastic Surgery's annual meeting in Washington, D.C., in April 2010. At that meeting, surgeons responded very positively to the device's ease of use and clear benefits, including time saved in the operating room and the reduced potential for knot-related complications.

*Compared to standard suture methods. Covidien V-Loc 180 Absorbable Wound Closure Device Time Study, Robert T. Grant, MD, FACS New York-Presbyterian Hospital, Argent Global Services.Utilization of a Porcine Model to Demonstrate the Efficacy of an Absorbable Barbed Suture for Dermal Closure, UTSW, S. Brown. Data on file.

ABOUT COVIDIEN

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2009 revenue of $10.7 billion, Covidien has 42,000 employees worldwide in more than 60 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.

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