top of page
CERTIFICATES
Validity of MDD certificate during MDR transition

Intended use (in Ukraine)
The ELUTAX “3” family of paclitaxel-coated balloon catheters is intended for the
treatment of atherosclerotic or fibrotic strictures in hollow organs - vascular, ureter, urethra and biliary.
​
The device achieves its intended therapeutic effect by mechanical dilatation of the stenosed lumen
and local drug delivery using a balloon coated with 2.2 μg/mm² Paclitaxel and 0.7 μg/mm² Dextran,
serving as a hydrophilic excipient.
​
outside Ukraine intended use depends on national registrations and can be different.
​
CE-Certificates VIAR
bottom of page




