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The V-Soft Line™ barbed device comprised of dyed polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues.

The V-Soft Line™ synthetic absorbable PDO suture with needle is made of polydioxanone. The pigment for the violet dye is D&C Violet No.2. The V-Soft Line™ is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue. The barbed sutures are pre-loaded and are not attached to the needle.

Each dyed (violet) suture has bi-directional barbs along the long axis of the suture monofilament with needle attachment. The V-Soft Line™ Synthetic Absorbable PDO suture with needle approximates tissue without the need to tie surgical knots, by using the opposing barbs on the surface to embed in the tissues after the surgeon precisely places the suture within the tissues.

The proposed suture is available in 2, 2-0, and 3-0 suture sizes, which are the sizes identified in the currently recognized Unites States Pharmacopeia.

The V-Soft Line™ is barbed to two sections on suture and the barbs on each section are opposite direction each other. The reason that this suture has each opposite barb direction is not to slide and move to forth and back and to fix well. Therefore, the effectiveness of suture for treatment can be improved.

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