DESCRIPTION: Trofilen is a synthetic, non-absorbable sterile surgical monofilament suture. It is made of an biologically inert polymer Polyvinylidene flouride (PVDF). Trofilen is dyed blue (Copper Phtalocyanine blue) for higher visibility. Trofilen meets all requirements for non-absorbable surgical sutures specified by the European Pharmacopoeia (EP) and United States Pharmacopoeia (USP).

INTENDED PURPOSE: Trofilen is intended for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological surgery and plastic surgery.

Single use only.

CLINICAL PERFORMANCE CHARASTERISTICS: Trofilen suture elicits a minimal acute inflammatory reaction in tissue, which is followed by gradual encapsulation of the suture by fibrous connective tissue. Trofilen is not absorbed, nor is it subject to degradation or weakening by the action of tissue enzymes. Due to its biological inertness, Trofilen is recommended for use where the least possible suture reaction is desired. As a monofilament, it has been successfully employed in surgical wounds which subsequently become infected or contaminated where it can minimize later sinus formation and suture extrusion.

CLINICAL BENEFIT: Trofilen sutures are used to approximate tissues when used for suturing open wounds hence limiting infection. Trofilen sutures are also used as a fixation system for soft tissues or other devices. Trofilen is not absorbed, nor is it subject to degradation or weakening by the action of tissue enzymes. The lack of adherence to tissues has facilitated the use of Trofilen as a pull-out suture.