Biopolymer GmbH & Co.KG - Germany
VesicoUreteral Reflux
Biopolymer GmbH & Co.KG - Germany
Treatment Options:
1. Medications: antibiotics such as
cephalosporins, Bactrim,
Amoxicillin.
2. Surgical Procedures: laparoscopic,
open procedures ( cohen procedure,
leadbetter-politano procedure)
3. Minimal surgery procedures: bulking
agents – Ureteral injection of implant
material.
Biopolymer GmbH & Co.KG - Germany
Treatment Options:
Urethral Injections – Bulking Agents:
Is a minimal surgical procedure providing
An alternative in treatment options:
The Ideal Bulking agent of choice must
include following charecteristics:
1. Biocompatible.
2. Biodegradable.
3. Bio-stable: no deformation after
injection.
4. No Migration after implantion.
5. No erosion after implantion.
6. Easy to applicate – without the need
to apply pressure when injecting.
Biopolymer GmbH & Co.KG - Germany
Treatment Options:
Available Bulking Agents for VUR:
1. Vantris: polyacrylate polyalcohol
copolymer immersed in 40% glycerol
solution carrier. It is non-resorbable –
permanent treatment.
2. Deflux: dextranomere microspheres
50mg/ml in a carrier gel of non-animal
stabilized hyaluronic acid 15mg/ml.
3. CRM Vurdex:
DEAE-Sephadex – dextran positively
charged dextranomere.
4. CRM Vurdex composition:
Sodium hyaluronate cross linked
17mg
DEAE Sephadex Dextran + charge 50mg
Sodium chloride
6.9mg
Water for injection
1.0ml
Biopolymer GmbH & Co.KG - Germany
CRM Vurdex designed Technolgy:
Why to use Urodex ? What is the added
Benefits of CRM Vurdex ?
In order to realize the added benefits of
CRM Vurdex, a summary explaining the
designation technology of the product will
answer many questions that may arise.
1. In VUR and as the condition is resulting from mechanical failure of valvular mechanism
of ureter to prevent urine reflux, basically a material that acts as
a bulking agent is needed in order to act in increased tissue thickness at injection site
that will aid in complete closure when muscles plays its normal role to prevent reflux.
and accordingly, the material of choice was DEAE-DEXTRAN ( DiethylaminoethylDextran) , the choice was based upon that Dextran is a Biocompatible , Biodegradable,
non-immunogenic molecule.
Dextran: consists of linked glucan with side chains attached to the 3-position of the
backbone glucose units, and it is produced by bacterial fermentation process ( nonanimal origin ).
Biopolymer GmbH & Co.KG - Germany
CRM Vurdex designed Technolgy:
2. DEAE-Dextran Biomaterial cannot be introduced by injection
And as the concept of the products is based upon – minimal
Surgical procedure – a carrier material is needed to carry the
DEAE-DEXTRAN to site of implantation, the choice of carrier
material was the specially designed cross linked hyaluronic acid
Technically adjusted to play the role of a ( carrier ), again the
choice was upon that HA is a biocompatible, biodegradable,
Non-immunogenic molecule.
3. After that and as a long duration effect is favorable in treatment of VUR the
Specially designed cross linking process was applied to DEAE-DEXTRAN to obtain a cross
Linked DEAE-DEXTRANOMERE or what is called a DEAE-Sephadex-Dextran , Sephadex
Is a trade mark for cross linked dextran, where cross linking process results in a long term
Duration of the implant to be degraded gradually.
Biopolymer GmbH & Co.KG - Germany
CRM VURDEX designed Technolgy:
4. Finally, a ( fine tuning ) process was created by Biopolymer
GmbH – Germany to ensure maximum effect results outcome for
the product ( CRM Vurdex ) to be unique and distinguished in
VUR Treatment options, the ( fine tuning ) was made by creating
a positive charge on DEAE-Sephadex – Dextran which stimulates
collagen formation in site of implantation and leading by that for
optimum results in treatment of VUR by stimulating tissue
regeneration process.
Accordingly, DEAE-Sephadex-Dextran is a polycationic cross
linked dextran with tissue regeneration stimulating effect.
5. Accordingly, the benefits of CRM Vurdex are summarized as following:
A. Biocompatible: as the used materials is a natural component of human body tissues, it
is non-immunogenic ( non-animal origin ), and biocompatibility is optimal due to
formation of fibroblast and collagen fibers that surrounds the microparticles.
B. Biodegradable: the used materials are completely degradable with safe clinical profile.
C. Long action duration: due to cross linking process that extends up to 5 five years.
D. No Migration from implant site: due to positively charged microparticles – the positive
charge plays a role in ( ancoring ) the implant through inter-cellular interactions leading
to fibroblasts and collagen fibers surrounding the implant material as well that
microparticles size used ensures no migration ( safe particles size – 80 micron ).
E. Stimulation of collagen formation: due to positive charges.
Biopolymer GmbH & Co.KG - Germany
CRM Vurdex:
CRM Vurdex:
1 syringe – 1.0ml
sterile needle 350mm
3.7Fr
Implantation procedure:
Video is available.
Biopolymer GmbH & Co.KG - Germany
Clinical trials
Biopolymer GmbH & Co.KG - Germany
Clinical trials
Biopolymer GmbH & Co.KG - Germany
Thank You