* In a porcine model.
† Mesh should be large enough that sufficient overlap of the fascial defect on all sides is achieved.
‡ ULTRAPRO ADVANCED Macroporous Partially Absorbable Mesh. Instructions for Use. Ethicon, Inc.
§ In porcine flank benchtop testing versus two other absorbable fixation devices
Superior acute holding strength at various deployment angles
¶ Preclinical data and reported experience suggest having the fixation points at least 1cm from the edge of the mesh. Fixation points should be sufficiently spaced so as not to create a mechanical weakness point on the reconstruction, and to reduce the likelihood of organ entrapment, and/or recurrence.
\\ In order to avoid migration of the Plug, it must be adequately fixated to the fascia
¥ Patients experienced significantly greater comfort with DERMABOND ADVANCED Adhesive at 6 weeks (P < 0.05) and 6 months (P < 0.01). In a similar retrospective study of 670 patients, patient comfort and satisfaction were also superior with DERMABOND ADVANCED Adhesive. (Dermabond claims matrix-043053-151106)
1. Data on file. Ethicon, Inc. Vailhe E. Report for 510k testing for ETHICON ULTRAPRO ADVANCED, Version 1 (AST-2014-0415, technical report)
2. Data on file. Ethicon, Inc. Handling and design characteristics of flat mesh prototypes study report. 2013.
3. ULTRAPRO ADVANCED™ Macroporous Partially Absorbable Mesh Consolidated Claims Matrix 052260-160428
ULTRAPRO ADVANCED™ Macroporous Partially Absorbable Mesh is designed for exceptional intraoperative handling.
4. Cardinale M. Angle Fire competitive test AST 2010-0199
5. Cardinale M. Comparison of acute holding strength of an absorbable strap fixation device in porcine flank at various implantation angles (technical report)
6. DERMABOND ADVANCED® Topical Skin Adhesive Consolidated Claims Matrix 043053-151106
DERMABOND ADVANCED® Topical Skin Adhesive significantly improves patient comfort and satisfaction.
Patient preference for DERMABOND ADVANCED Adhesive was significant at all time points.
7. Nipshagen MD, Hage JJ, Beekman WH. Use of 2-octyl-cyanoacrylate skin adhesive (DERMABOND®) for wound closure following reduction mammaplasty: a prospective, randomized intervention study. Plast Reconstr Surg. 2008;122(1):10-18.
8. Scott GR, Carson CL, Borah GL. Dermabond skin closures for bilateral reduction mammaplasties: a review of 255 consecutive cases. Plast Reconstr Surg. 2007;120(6):1460-1465.