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Zuidex
 
 

The procedure provides immediate and sustained relief from the symptoms of SUI. NASHA/Dx gel is clinically proven safe with extensive, worldwide use for childhood vesicoureteral reflux (VUR).
NASHA/Dx gel is marketed under the trade name Deflux for childhood VUR

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The Zuidex System Delivers Effective Stress Urinary Incontinence (SUI) Treatment providing Immediate and Sustained Relief from SUI

In an open, prospective, multi-center study conducted in female patients 18 years of age or older with urodynamically verified SUI for an average of 5 years, over 75% of women were either completely dry or improved* immediately following treatment. Patients experienced an 80% reduction in urinary leakage and a 79% reduction in the number of incontinence episodes per day. Both reductions were statistically significant and those results were maintained through the 12-month follow-up.

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NASH/Dx Gel Provides a Proven Advantage for Stress Urinary Incontinence (SUI)

Zuidex gel is a unique copolymer composed of NASHA and dextranomer. The copolymer works to add volume to the urethral wall which provides structure for host connective tissue.


Unique properties for optimal performance

NASHA/Dx gel gradually biodegrades allowing new connective tissue to form without calcification or major tissue changes, maintaining relief through tissue augmentation.

NASHA/Dx gel is the only FDA-approved agent for the treatment of childhood VUR, with more than 20,000 children successfully treated with no reported persistent adverse events.

NASHA/Dx gel is biocompatible and non-immunogenic in humans, allowing effective relief with no risk of rejection or allergic reaction.

The pseudoplastic properties of the gel allow for easy manual administration through thin needles and the diameter of dextranomer microspheres ranges from 80 to 250 microns, a size that assures no migration.

 

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The Implacer Offers Precise Standardized Delivery of NASHA/Dx gel
The innovative Implacer is part of the Zuidex System and standardizes the procedure for NASHA/Dx gel implacement, making it a suitable first-line treatment after behavioral therapy.

The Implacer makes delivery simple and accurate

The Implacer device unfolds and fixates the urethra wall to ensure symmetrical placement of NASHA/Dx gel at 4 evenly-spaced locations around the urethra.The concept and design of the Implacer obviates the need for an operating theater and visualization during implantation.

Magnetic resonance imaging (MRI) has confirmed that the implants are accurately positioned without cystoscopy.

A safe procedure that's Convenient for Stress Urinary Incontienence (SUI) Patients

The Zuidex Systems excellent risk-to-benefit ratio meets patient desire for a minor procedure with a low risk of complications.No major complications have been associated with the injection procedure, and there have been no reported safety concerns up to 7 years following NASHA/Dx administration.

The standardized implacement procedure avoids long-term complications associated with surgery.In addition, treatment with Zuidex™ does not preclude future surgical intervention, since implacement therapy with NASHA/Dx has been shown to cause no major tissue changes.

Whats more, SUI patients undergoing the procedure are able to return to normal daily activities quickly.

Zuidex, like all treatments, is associated with some side effects. The most common adverse reactions associated with the procedure were discomfort around the injection area, hematuria, and urinary tract infection. The majority of these were mild, not related to the NASHA/Dx gel, and all were transient. As with other injectable agents occasional sterile abscess formations have been observed post Zuidex™ treatment. No change in urodynamic parameters (urethral closure pressure, bladder capacity, micturition frequency, and post-voiding residual urine) was observed following treatment.

 
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