Macroplastique® for Stress Urinary Incontinence is an injectable soft-tissue bulking agent used to treat adult female stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency (ISD). The soft, textured Macroplastique implants are made of solid silicone elastomer and suspended in a watersoluble, bio-excretable carrier gel.
The indications for Macroplastique are different in the US and outside of the US. Outside of the US, MPQ is indicated to treat female SUI primarily due to Intrinsic Sphincter Deficiency (ISD). It is also used to treat males with SUI typically following a TURP or radical prostatectomy. MPQ can also treat vesicoureteral reflux.
In a multi-center clinical trial, Macroplastique demonstrated excellent clinical efficacy.
PATIENT OUTCOMES WITH MACROPLASTIQUE (1)
1. Ghoniem, G., Corcos, J., Comiter, C., Bernhard, P., Westney, O.L. & Herschorn, S. (2009). Cross-linked polydimethysiloxane injection for female stress urinary incontinence: Results of a multicenter, randomized, controlled, single-blind study. J Urol, 181, 204-210
*122 patients received Macroplastique treatment. Subjects who were lost to follow-up or withdrawn are considered failures.
** Of 102 subjects attending 12 month follow-up.
*** Of 84 subjects attending 24 month follow-up.In a multi-center clinical trial, Macroplastique demonstrated excellent clinical efficacy. ”
MPQ-2.5 Macroplastique Implants, One 2.5 ml unit
AD-US Reusable Administration Device, includes syringe adapter
MRN-420 Rigid Endoscopic Needle 3.8 Fr. shaft x 14.5” (370 mm) long with 20 gauge tip x 0.54” (14 mm) long
MRN-518 Rigid Endoscopic Needle 5 Fr. shaft x 15” (380 mm) long with 18 gauge tip x 0.54” (14 mm) long
Macroplastique® Implants is a sterile, nonpyrogenic, latex-free, injectable tissue bulking agent comprised of flexible, soft textured implants of heat-vulcanized polydimethylsiloxane (a solid silicone elastomer) suspended in a bio-excretable polyvinylpyrrolidone (PVP) carrier gel. When implanted in the urethral wall between the mid-urethra and the bladder neck, the implants bulk tissue and create coaptation of the urethra.
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