CONDITIONS REQUIRING IsolveTEM

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2 CONDITIONS REQUIRING IsolveTEM The IsolveTEM procedure uses a soft elastic synthetic mesh to restore normal anatomy and tissue contour, and corrects symptoms in the case of a Pelvic Organ Prolapse (POP).. Uterine prolapse (procidentia) occurs when the muscles and ligaments are weakened and the woman still has a uterus, which gradually descends into the vagina. The IsolveTEM is placed over the upper portion of the vagina, the apex.. Small bowel prolapse (enterocele) occurs when the intestine protrudes into the vagina. Enteroceles can occur at the front, back or top. The IsolveTEM is placed between the vaginal wall and the bowel in order to prevent herniation (protrusion) of the bowel.. Rectal prolapse (rectocele) occurs when the rectum protrudes or herniates into the vagina. The IsolveTEM is placed between between the vaginal wall land and the wall of the rectum to provide reinforcement and correct the protrusion of the wall of the rectum into the vaginal wall..bladder prolapse (cystocele) occurs when the wall between the bladder and the vagina weakens, causing the bladder to protude or herniate into the vaginal wall. The IsolveTEM is placed between the bladder and the vaginal wall. This corrects the herniation of the bladder into the vaginal wall. 1

3 PRODUCT BENEFITS - For prolapse repair - Very easy to use - Cost-reducing material procedure Symptoms Around 50% procent of child-bearing women show signs of a pelvic organ prolapse on examination. Pelvic organ prolapse occurs when the tissue no longer supports the pelvic organs. Symptoms are: - Bulging feeling of tissue or organs -Urinary leakage - Constipation -Sexual inactivity -Abdominal back pain Risk factors Pregnancy may compromise the effect of a pelvic organ prolapse procedure. The procedure is not indicated for women who desire to have children or women younger than 18 years old. 2

4 PRODUCT BENEFITS Material - More than 5,000 microgrips - Strong monafilaments, which are considered safer than multifilaments (reduced bacterial infection risk) - Increased durability and strength of repair - The mesh has an anatomically superior design to improve vaginal mobility - Polypropolyne meshes ar the most commonly manufactured mesh type - Innovative design promotes connective tissue ingrowth - Variable porosity leads to increased elasticity - Reduced contracture Less pain - No tension because of tension free flexible mesh material - Less post-operative pain results in lower pain management costs - No mesh shrinkage due to flexible sutures - High patient satisfaction 3

5 PRODUCT BENEFITS Cost saving - Polypropylene is a low-cost material - Very low anatomical failure eliminates need for post-operative pain therapy - Improved performance minimises hospital stay - Faster return to work (on average within 3.6 weeks) - Improves normal function faster than with medical therapy Easy to use - Innovative punched material with blue line for better visibility - Punch holes to prevent fraying - Easy orientation - Doesn t stick to itself - Flexible and soft - Less post-operative pain results in lower pain management cost - No mesh shrinking due to flexible sutures - High patient satisfaction 4

6 PRODUCT BENEFITS Innovative design The IsolveTEM offers an innovative design for ultimate support and stabilization of the pelvic area. The strong knit in the lateral sides provides optimal strength and stability. Open-knitted design at the center offers multidirectional strength and elasticity. The mesh can be trimmed with easy-to-use punch holes with blue lines for better visibility. Total Elastic Mesh: for total, anterior and posterior use. All-in-one solution by IsolveMedical. 5

7 HIGH SUCCES RATE, LOW FAILURE High tear propagation resistance Conventional textile implants have a weak point: once torn or cut a zipper effect frequently occurs the mesh continues to tear (mesh rupture). This does not happen with the Isolve Tem. The multiple meshing technique used in our warp-knitted structure effectively eliminates this undesired effect. Tear propagation resistance is one of the basic properties common to all our implants. Conventional Mesh IsolveTem 6

8 HIGH SUCCES RATE, LOW FAILURE IsolveTem Anterior & Apical study Design: multi-center study, anterior & apical 12-month follow-up, 142 patients ( 125 at 12 months) Complications: 5.6% UTIs and mesh extrusion (each), 4.2% dyspareunia, 3.5% buttock pain, de novo SUI and urinary retention (each), 2.1% hematoma and granuloma formation (each), all other AEs at <2%. Conclusion: Twelve-month data shows thatisolvetem iseffectivewithfewcomplications, lowmeshextrusionratesandhighpatientsatisfaction. 7

9 INNOVATIVE MATERIAL Lightweight and soft mesh IsolveTEM is designed to be lightweight and soft to conform to the anatomy and lie flat. The knitted monofilament polypropylene mesh used in IsolveTEM has a soft knit in the central section for compliant organ support and host tissue ingrowth, and a strong knit laterally to provide improved strength for tension-freefixation of the mesh. The open-knit design offers multidirectional strength and elasticity that allows the synthetic mesh to be trimmed at the physician s discretion without unraveling. 8

10 INNOVATIVE MATERIAL Intended use IsolveTEM is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal prolapse where surgical treatment is indicated either as mechanical support or as bridging material for the fascial defect. IsolveTEM is designed to support the underlying tissue and organs in the case of a pelvic organ prolapse repair. IsolveTEM is designed to be minimally invasive. Different techniques are used to insert the IsolveTEM with small incisions into the inner thigh or buttocks. IsolveTEM allows maximum fibrous tissue ingrowth so the mesh can be fully incorporated into the body. Performance Animal studies show that implantation of IsolveTEM elicits a minimal to mild inflammation reaction which will pass once the mesh is incorporated into adjacent tissue. The elastic mesh structure keeps the mesh soft, pliable and normal. The success rate varies depending on the type of prolapse. The success rate for pelvic prolapse repair is 80% to 90%. 8

11 CHARACTERISTICS IsolveTEM Thickness (mills) 21.9 (body) 31.5 (arms) Unit weight (mg/cm2) 7.6 Porosity (%) 63.4 (body) 45.7 (arms) Burst strength (psi) Flexibility (mg/cm) Tear strength (lb) Knitting machine axis: 5.2 Across machine axis: 5.4 Suture pull-out (lb) Knitting machine axis: 5.96 Across machine axis: 6.55 Tensile strength (lb) Knitting machine axis: 20.9 Across machine axis:

12 REFERENCES Reisenauer C, Kirschniak A, Drews U, Wallwiener D, Anatomical Conditions for pelvic floor reconstruction with polypropolyne implant and its application for the treatment of vaginal prolapse. Eur. J. Obstet. Gynecol. Repor. Biol Apr; 131 (2): Cosson, M. Et al. Prolift (mesh (gynaecare) for Pelvic Organ Prolapse Surgical treatment using the TVM group technique: a retrospective study of 96 woman of less than 50 years old. Cosson et al. Prolift (mesh (Gynecare) for pelvic organ prolapse surgical treatment using the TVM Group technique: a retrospective study of 687 patients. Cobb WS, Burns JM, Peindl RD, Carbonell AM, Matthews BD, Kercher KW, Heniford BT. Textile Analysis of Heavy Weight, Mid- Weight and Light Weight Polypropylene Mesh in a Porcine Ventral Hernia Model. J Surg Res. 2006;136(1):1-7. Cobb. et al. The argument for lightwieght polypropyle mesh in hernia repair. Surg Innov. 12 (1): (2005) Heniford, B.T.: Textile analysis of lightweight and midweight polypropolyne mesh in a porcine ventral hernia model. Oral presentation abstract. Academic Surgeins Conference, Houston, November 2004, USA. Pascual et al. Surgery. (2008) 144 (3). Junge et al. Hernia (2005) 9:212. Ethicon Inc. Biocompatible: monocryl layer reduce inflammatory response and tissue l integration. Reduces Shrinkage effect] Altman D. Vayrynen T., Engh ME, et al. Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. N. Engl J. Med. 2011; 365 (19): Altman D., Vayrynen T, Engh ME, Axelsen S., Falconer C; For the Nordic Transvaginal Mesh Group. Short-term outcome after transvaginal mesh repair of pelvic organ prolapse. Int. Urogynecol J. Pelvic Floor Dysfunct Dec B.Fatton,J.Amblard,P.Debodinance,M.Cosson,B.Jacquetin,Transvaginalrepairofgenitalprolapse:preliminaryresultsofa newtensionhfreevaginalmesh(prolifttmtechnicque)acaseseriesmulticentricstudy.int/urogynecolj(2007)18:743:752 10

13 PRECAUTIONS Sterility The IsolveTEM is sterilized by ethylene oxide. DO NOT RESTERILIZE. DO NOT REUSE. Do not use package when openend or damaged. Discard unopened, unused mesh. How supplied IsolveTEM is available in single sterile packets. Storage Recommended storage conditions: controlled room temperature and relative humidity (approximately 25 C, 60% RH) away from moisture and direct heat. Do not use after expiry date. Adverse reactions As with most surgical procedures, potential adverse reactions may occur. Some potential adverse reactions to surgical procedures to correct pelvic organ prolapse include: HPain / discomfort/ irritation HInflammation (redness, heat, pain, swelling resulting from surgery) - Mesh erosion (presence of suture or mesh material within the organs surrounding the vagina) - Foreign body (allergic) reaction to mesh implant - Contracture (mesh shortening due to scar tissue) - Dyspareunia (pain during intercourse) For more information please contact IsolveMedical at: or info@isolvemedical.com IsolveMedical 11