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Smartmesh™ is the only patent protected mesh designed for pelvic floor restoration by a urogynecologist exclusively for the female anatomy. Smartmesh™ has been used in over 1,800 pelvic floor repairs, has four years of safety data recorded, and has a less than 1% erosion rate in vaginal mesh repair [viii].
It is made from polypropylene mesh which has been used as a pelvic implant material for over 50 years. Smartmesh™ has a macroporous (1.8mm pores) uniform polypropylene warp knit structure and is the lightest pure polypropylene mesh available at 19 grams per sq meter (testing on file)[iii].
Smartmesh™ has patented interstitial Smartpores™ of approximately 100 micron diameter which allow for preferential fibroblastic entry and collagen growth[v]. It has also demonstrated greater biocompatibility with less chronic inflammation than heavier mesh, 71% more mature type 1 collagen and stronger new collagen formation than heavier mesh[vi].
Smartmesh™ can aid defense against infection, because macrophages and neutrophils can easily enter the pores to chase the inevitabley bacteria that colonise meshes. Fibroblasts will enter pores that are 50 to 200 microns in size. Bacteria will go into any hole that is 10 microns or bigger but macrophages and neutrophils will enter pores that are over 50 microns in size. Our 100 micron smartpores are ideal for both purposes [vi].
Restorelle™ is the ideal surgical solution for treating pelvic organ prolapse (POP) utilizing the physiologically compatible ultra lightweight Smartmesh™ Technology for optimal tissue integration and near-zero erosion rates. It is the only mesh designed exclusively by a gynecologist for pelvic floor restoration.
In a series of 119 vaginal vault and posterior repairs using Restorelle™, there was a 99% cure rate with no erosions reported. No de novo dyspareunia was reported[i].
In over 1,800 pelvic floor restoration (PFR) cases, Mpathy Medical has seen a less than 1% erosion rate in vaginal mesh repair with Restorelle [viii]. A 3 year series of 201 patients (360 total mesh implants), found a cure rate of 99.5% and erosion rate of only 0.28% (or one mesh erosion) [viv].
Surgeons find Restorelle™ to be soft and easy to handle during vaginal and laparoscopic surgery. Its hydrophilic properties allow the mesh to conform and mold precisely to the anatomical site allowing for easier fixation for the surgeon. It can be cut or trimmed easily and will not fray or leave behind extraneous fibers. For vaginal repairs, the isotropic multi-directional stretch characteristics allow the mesh to extend slightly with the body, just as natural tissue would[iii].
Restorelle™ is non-palpable for the patient and her partner. This is a vital attribute for optimization of sexual function.
The vagina also appears to maintain postoperative elasticity, associated with optimal sexual, urinary and bowel function[iv]. Omnisure™ Clinical Data Summary
Omnisure is a refined procedure designed by a surgeon specifically for treating stress urinary incontinence. It combines a novel full length sling approach uisg the narrowest needle option with the superior Smartmesh™ Technology.
An ongoing multi-center (25 US surgeons) observational study of 162 patients found [vv]:
- 90.2% cure rate
- 99% patient satisfaction
- 2.6% complication rate (3 out of 113 patients reports transient thigh or buttock pain)
Minitape® is specifically designed to perform like a full sling with a minimal amount of mesh mass. It is suitable for all types of patients. Minitape® is a stabilized, adjustable sling used for treating female stress urinary incontinence (SUI). The Minitape® procedure delivers an early postoperative adjustment capability up to 72 hours following surgery.
Mpathy Medical has over two years of data on Minitape® which shows a good safety profile and a cure rate of 97% [vii]. Specifically, there were has been a low incident of bladder perforations, erosions and major complications reported. Minitape® is capable of placement under local anesthesia and in an office setting.
Unstabilized minislings are not as effective as full length slings with short-term reports of lower efficacy. Stabilization of the sling for 72 hours, as with the Minitape® procedure appears in preliminary clinical studies to give benchmark levels of effectiveness, associated with full-length slings.
In the first 72 post-operative hours, Minitape® is capable of adjustment or fine-tuning by loosening or tightening the sling. Early experience shows approximately 40% of a primary SUI group may need some fine-tuning and in so doing it is hoped to further improve the cure/improvement rate.
Minitape® is indicated for all women with USI, including primary and repeat surgeries, mixed incontinence, intrinsic sphincter deficiency and with co-existing voiding disorder. It has particular benefit in these latter groups where peri-operative tensioning is particularly difficult, and fine-tuning against symptoms once mobilized is advantageous.
Minitape® utilizes the physiologically compatible ultra lightweight Smartmesh™ technology for optimal tissue integration and near-zero erosion rates. Smartmesh™ is the only patent -protected mesh designed exclusively by a gynecologist for pelvic floor restoration. Smartmesh™ has been used in over 1,800 pelvic floor repairs and has four years of recorded safety data.
Minitape® uses a unique closed knit technology with smooth sling edges and maintains broad support for the urethra. There is minimal mesh extension, attenuation and thinning under traction.
[i] Hawthorn, R. et al (2007). Use of an ultralightweight mesh in vaginal vault repair to minimise complications: A two-centre observation study. British International Congress of Obstetrics & Gynaecology.
[ii] North, C.E. (2005) et al A preliminary study to compare the vaginal palpability of two different mesh materials used for laparoscopic sacrocolpopexy. International Urogynecology Journal.
[iii] Pandit, A.S (2004). Design of surgical meshes - an engineering prespective. Technology and Health Care, 51-65.
[iv] Higgs, P.J. et al (2005). Long term review of laparoscopic sacrocolpopexy. BJOG 112; 1134-38.
[v] Pourdeyhini, B. (1989). Porosity of surgical mesh fabrics: New technology. Journal of Biomedical Materials Research, 23, 145-52.
[vi] Greca, F.H. et al (2007) The influence of porosity on integration histology of two polypropylene meshes for treatment of abdominal wall defects in dogs. Hernia, (12), 45-49.
[vii] Alinsod, R (2009). Recent advances in tape slings for female urinary stress incontinence. Reviews in Obstetrics & Gynecology. 2(1); 46-50.
[viii] Data on file.
[viv] Alinsod, R. (2008) Long term outcomes of vaginal pelvic floor repair using an ultra lightweight mesh. Manuscript submitted for publication.
[vv] Arendt, K (2009, November). Initial Experience and Results Using Omnisure and Minitape Slings. Symposium conducted at the meeting of the American Association of Gynecologic Laparoscopists, Orlando, FL. |
