Upsylon Y-Mesh and ™ Colpassist ™ Vaginal Positioning Device It’s more than light-weight mesh, It’s ease of positioning and fixation. Upsylon™ Y-Mesh and Colpassist™ Vaginal Positioning Device Upsylon Y-Mesh The Upsylon Y-Mesh features lightweight, low surface area technology to minimize mesh contact with the vaginal wall. The mesh handling characteristics, large pores and blue color are designed to ease positioning and fixation to assist with placement. Upsylon Leg Attachment Strength and Method Comparison to Restorelle Y Mesh and 13 knot suture pattern. Mesh Attachment Strength (Average) Upsylon™ Y-Mesh n=30 23.2 lbs Restorelle Y Mesh n=9 16.5 lbs ™ Designed for strength with suture knotted at 13 points. Data on file at Boston Scientific Results based on bench testing. Bench testing may not be necessarily indicative of clinical performance. Vaginal / Short Leg Attachment Line Sacrum / Long Leg 2 1 3 4 5 The leg attachment suture is knotted at 11 locations across the mesh. In addition, there are two back stitches for a total of 13 knots. 6 7 8 9 10 11 12 13 It’s more than light-weight mesh, It’s ease of positioning and fixation. •Mesh characteristics designed to provide stability for positioning and fixation Restorelle™ Y Mesh Alyte™ Y-Mesh Graft (Sacral) Alyte Y-Mesh Graft (Vaginal) Artisyn™ Y-Shaped Mesh IntePro™ Y Graft The Basics Mesh Weight (g/m2) 25 20 33.5 16.5 28* 52 Pore Size (mm2) 2.8 3.0 2.9*** 2.9*** 3.9** Fiber Diameter (microns) 100 75 90 90 100 100 Length of Fiber (cm/cm2) 35.4 48.7 58.5 28.8 39.6 73.6 Surface Area Ratio 1.11 1.17 1.65 .81 1.24* 2.31 Thickness (microns) 200 305 377 287 533 527 0.53 0.11 Not Tested 0.15 0.71** Not Tested 18.3 11.5 18.3 8.8 13.5 23.3 Blue w/ Natural Center Stripe Natural Natural w/Blue Stripe Natural w/Blue Stripes Natural w/Blue Stripes Natural Mesh Handling Upsylon™ Y-Mesh (BSC) Low Surface Area •Blue color designed to provide enhanced visualization of mesh against tissue Pliability (ASTM Standard D-4032) Stiffness (N) Suture Pull-Out (Machine Direction) Color Strength (N) Mesh Color Data on file at Boston Scientific Results based on bench testing. Bench testing may not be necessarily indicative of clinical performance. * Post-absorption ** Pre-absorption Major: 6.9*** Minor: 3.4*** *** Including Cross Fiber 1 Handling Characteristics Handling Characteristics Handling Characteristics Handling Characteristics 2 533 527 2 2 Handling Characteristics2 533 527 533 527 533 23.3 527 23.3 23.3 Upsylon Y-Mesh Upsylon Y-Mesh Upsylon Y-Mesh 23.3 Upsylon Y-Mesh 18.3 18.3 18.3 Alyte Y Mesh GraftAlyte (Vaginal) Y Mesh GraftAlyte (Vaginal) Y Mesh Graft (Vaginal) 287 305 287 305 287 305 18.3 13.50.71 Alyte Y Mesh Graft (Vaginal) Restorelle Y-Mesh Restorelle Y-Mesh Restorelle Y-Mesh 13.5 13.5 0.71 0.71 28711.5 305 8.8 11.5 0.538.8 11.5 0.53 200 200 200 Y-Mesh 13.5 0.53 8.8 Artisyn Y-Shaped Mesh* ArtisynPre-absorption Y-Shaped0.71 Mesh* ArtisynPre-absorption Y-ShapedRestorelle Mesh* Pre-absorption 11.5 0.53 200 8.8 0.15 0.11 Thickness (microns) Thickness (microns) 0.15 0.11 Thickness Suture Pull Out Suture Pull Out Suture Pliability Pull Out Pliability IntePro Y Graft 0.15 0.11 Pliability IntePro Y Graft 0.15 0.11 (Machine (microns) Direction) (Machine N Direction) (ASTM (Machine N D Standard Direction) (ASTM D4032) N Pull DN Standard D4032)DNStandard D4032) N Thickness Suture Out(ASTM Pliability (microns) (Machine Direction) N IntePro Y Graft Artisyn Y-Shaped Mesh* Pre-absorption (ASTM D Standard D4032) N IntePro Y Graft Colpassist™ Vaginal Positioning Device The Colpassist Vaginal Positioning Device is the first device specifically designed for vaginal positioning in gynecologic procedures and as a suturing platform for vaginal wall fixation during sacrocolpopexy. • Two size end options create a flat suturing surface • Multi-direction vaginal manipulation during dissection and mesh placement Figure 1: Picture of posterior dissection performed with Colpassist Vaginal Positioning Device providing positioning. Upsylon™ Y-Mesh and Colpassist Vaginal Positioning Device Order Number 1 Description Unit M0068318200 Upsylon Y-Mesh Each M0068318210 Colpassist Vaginal Positioning Device Each M0068318220 Upsylon Y-Mesh and Colpassist Vaginal Positioning Device Kit Each uture pull-out testing per ASTM D882 in transverse direction of knit. Pliability/stiffness measured using a modified ASTM D4032 S (single layer of mesh 50mm x 90mm). Sample sizes range from 1-5 for non-BSC mesh products vs. 20 or more samples tested for BSC Mesh. Averages recorded where multiple samples were measured. Results based on bench testing. Bench testing may not be necessarily indicative of clinical performance. Upsylon and Colpassist are unregistered trademarks of Boston Scientific Corporation or its affiliates. All other trademarks are property of their respective owners. For Upsylon Y-Mesh: Caution: Federal (USA) law restricts this device to sale by or on the order of a physician trained in performing mesh procedures for surgical repair of pelvic organ prolapse. For Colpassist Vaginal Positioning Device: Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Please refer to package insert provided with these products for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events, and Instructions prior to using these products. Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 www.bostonscientific.com/gynecology Ordering Information 1.888.272.1001 © 2013 Boston Scientific Corporation or its affiliates. All rights reserved. WH-155601-AA 100 5/13
© Copyright 2024 ExpyDoc