Intended use:

The ELUTAX “3” family of paclitaxel-coated balloon catheters is intended for the

treatment of atherosclerotic or fibrotic strictures by opening-up a blocked passage by using a balloon which is coated with paclitaxel and dextran.

This includes​:

• Arteries and veins of the upper and lower limbs

• Coronary arteries

• Supra-aortic and intracranial vessels

• Arteriovenous fistulas

• Non-vascular conduits, such as the ureter and urethra

​

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. Use is limited to standard PTA or PTCA procedures by trained

healthcare professionals.

This pathology-based definition of intended use is fully consistent with the scope assessed and

accepted by the Notified Body under current MDD certification.