Short Overview

The STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Knotless Tissue Control Device is an antibacterial monofilament, synthetic absorbable device prepared from a copolymer of glycolide and ε-caprolactone. The device contains IRGACARE ®*MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 μg/m. The device is available in a dyed and undyed version. The pigment for the dyed version is D&C Violet No. 2. Poliglecaprone 25 copolymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption.

The STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Bidirectional Device Design consists of barbed suture material, armed with a surgical needle on each end. The device also contains an unbarbed center transition zone that facilitates the initiation of the device use. The STRATAFIX™ Spiral MONOCRYL™ Plus Device barbs allow for tissue approximation without the need to tie surgical knots.

While the formation of barbs in the STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Device reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in non-barbed suture materials also reduces their effective strength. For this reason, the strength of the STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Device can be compared to USP knot strength of non-barbed sutures. The actual diameter of the non-barbed section fiber is one size greater than the designated size with a maximum overage of 0.1 mm.

Ethicon, Instructions For Use, Stratafix. © Ethicon, Inc. 2022