MACROPLASTIQUE® / PLASTIQUE® Family of Products

MACROPLASTIQUE® - United States

Macroplastique® Urethral Bulking Agent

Macroplastique is an injectable soft-tissue bulking agent with proven performance since 2006.

Macroplastique is a treatment for adult women with stress urinary incontinence (SUI), primarily due to intrinsic sphincter deficiency.

Reference #: MPQ-2.5

PLASTIQUE® Family of Products – International

Macroplastique® Urethral Bulking Agent

Injectable soft-tissue bulking agent used to treat stress urinary incontinence (SUI) in men and women.

For women, MPQ is indicated to treat female SUI primarily due to Intrinsic Sphincter Deficiency (ISD). For SUI in males, MPQ is typically used following a TURP or radical prostatectomy. MPQ also treats vesicoureteral reflux.

Reference #s: MPQ-2.5 and MPQ-1.5

PTQ® Injectable Bulking Agent

Minimally invasive treatment for Fecal Incontinence.

PTQ is indicated for trans-sphincteric implantation in the Internal Anal Sphincter (IAS) for the treatment of passive fecal incontinence due to a weak or disrupted internal anal sphincter.

Reference #: PTQ-2.5

Some LABORIE products may not be available in certain regions.

Please contact your local LABORIE Sales Representative to learn more about the products available to you.

MKT-00036(A)

PREDICTABLE PRODUCT

Macroplastique® 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 water-soluble, bio-excretable carrier gel.

  • Non-degradable, non-resorbable
    • Uniquely designed to create an excellent open matrix for collagen deposition
    • Average implant size is 140 μm with the majority of implants between 120 – 600 μm
    • Size of initial bolus is maintained even after carrier gel is excreted
    • Administration Device ensures a controlled and precise implantation procedure
    • Suspension of implants in carrier gel makes Macroplastique easy to inject
    • Ready to use – no mixing or special storage

PROVEN PERFORMANCE

In a multi-center clinical trial, Macroplastique demonstrated excellent clinical efficacy.

PATIENT OUTCOMES WITH MACROPLASTIQUE1

  • At 12 Months
    • 62% of patients had an improvement ≥ 1 Stamey Grade*
    • 37% of patients were dry*
    • Physicians considered 80% of the patients dry or markedly improved**
    • 60% improvement from baseline in Incontinence Quality of Life surveys (IQOL)**"

At 24 Months

  • 75% of patients had an improvement ≥ 1 Stamey Grade***
  • 33% of patients were dry***
  • No serious treatment-related adverse events associated with Macroplastique"

"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 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

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.

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