Macroplastique® / Plastique® Family of Products

Macroplastique® / Plastique® Family of Products

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What is Macroplastique® / Plastique®?

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.

Macroplastique is supplied sterile in a pre-filled polypropylene syringe containing approximately 2.5 ml of product. The Macroplastique product is implanted using an administration device and an endoscopic injection needle recommended by Laborie Medical.

Macroplastique is a biocompatible, nonresorbable implant that allows tissue healing to occur. The synthetic implants remain in place at the implantation site as a result of the naturally occurring tissue response. The carrier gel is exchanged for tissue fluids containing host fibroblasts that subsequently deposit a collagen matrix around the individual implants, as well as around the periphery of the implanted material. After the exchange, the carrier gel is removed by the reticuloendothelial system and excreted unmetabolized from the body through the kidneys.

PHYSICIAN TRAINING

Macroplastique should only be used by someone properly trained in diagnostic and therapeutic cystoscopy.

Macroplastique is a safe and effective soft tissue bulking agent used as a treatment for adult women diagnosed with stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency (ISD)

INERT AND STABLE

“Macroplastique is comprised of nonresorbable, flexible, biocompatible, highly-textured implants of cross-linked, silicone elastomer polydimethylsiloxane (PDMS) suspended in a bio-excretable polyvinylpyrrolidone (PVP) carrier gel. The textured surface geometry of the implants is conducive to tissue ingrowth.

Macroplastique is made of silicone elastomer. This stable and inert form of silicone consists of highly cross-linked polymer molecules. This property distinguishes silicone elastomer from silicone gels and silicone oils, which contain few cross-linked molecules.

Silicone elastomer is a preferred material for medical devices such as pacemaker leads, catheters, shunts, artificial hips, and subdermal implants for controlled release of pharmaceuticals. ”

MPQ-2.5  Macroplastique Implants, One 2.5 ml unit

AD-US Reusable Administration Device, includes syringe adapter

MRN-420 Cogentix Medical 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 Cogentix Medical Rigid Endoscopic Needle5 Fr. shaft x 15” (380 mm) long with 18 gauge tip x 0.54” (14 mm) long