Macroplastique ^® Injectable Bulking Agent

for Adult Female Stress Urinary Incontinence

Macroplastique is an injectable soft-tissue bulking agent used to treat stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency (ISD). Macroplastique has been used in Europe since 1991 and has proven to be an effective and safe treatment alternative for those suffering from SUI.

Predictable Procedure

• Unique delivery system ensures precise implantation
• May be performed in the office

Permanent Implants

• Permanent implants: non-degradable, non-resorbable
• Soft, flexible, textured implant particles create an excellent matrix for collagen deposition
• Histological examination of tissue explants revealed no evidence of particle migration

Proven Performance
In a multi-center clinical study, Macroplastique demonstrated excellent clinical efficacy

• 122 patients received Macroplastique and were followed for 12 months from initial treatment No serious treatment-related adverse events were associated with Macroplastique procedures
  • 75 of 122 (61.5%) were improved at 12 months based on Stamey grade
  • 45 of 122 (36.8%) were dry based on Stamey grade
• Twenty-four month follow-up data were available on 84 Macroplastique subjects. Of these 84 subjects, 63 had improvement in Stamey Grade at 24 months, 28 of whom were dr.

Macroplastique is injected using a tunneling technique at the mid-urethral position

More Details

Administration Device

Indications

The Administration Device is indicated for the delivery of injectable materials contained in standard 3 cc syringes.

Description

The Administration Device (AD) is a chrome-plated die cast zinc, with chrome-plated brass adapters and stainless steel lever, syringe dosage rod, and pivot point with pin, for holding and delivering the contents of Uroplasty 3 cc syringes.

Limitations

Clean and sterilize the device prior to use using methods listed on page 3. After cleaning and sterilization, verify functionality prior to re-use.

End of life is normally determined by wear and damage due to use.

Download Full informative Manual PDF