VersaOne™ Faszienverschlusssystem

†Based on cadaver usability lab with 16 surgeons (13 of 16 surgeons agreed). The two devices are: a standard trocar and a fascial closure system. Preclinical results may not correlate with clinical performance in humans.

‡Based on usability lab with 16 surgeons (16 of 16 surgeons agreed). Preclinical results may not correlate with clinical performance in humans.

§Based on usability lab with 16 surgeons (13 of 16 surgeons agreed). Preclinical results may not correlate with clinical performance in humans.

ΩBite size determined by bench top testing which evaluated perpendicular distance between the edge of the cannula at the black O-ring point to the center of the suture passer.

†† Based on usability lab with 16 surgeons. (14 of 16 surgeons agreed). Preclinical results may not correlate with clinical performance in humans.

1. Based on internal validation report #RE00098009 Rev A, Double Time VersaOne™ fascial closure system Miami lab VOC (3/28). March 28, 2017. 

2. Based on internal validation report #RE00062341 Rev A, Summative usability of project DoubleTime VersaOne™ fascial closure system. Grainger Center for Simulation and Innovation (GCSI), NorthShore University Hospital, Evanston, IL, August 24-25, 2016.

3. Based on internal report #RE00079705, Revision 1, Fascial closure system bite size verification. January 31, 2017.