Technology
IFU

IFU Release Date: PRO2.0201.10 12/2022

For previous versions of the IFUs, please contact: quality@bluemedical.com

Innovative drug coated balloon that opens a window of opportunities with regard to treating coronary diseases in the best possible manner. Also available in Non-Compliant version, unique on the market!

Supported by independent scientific evidence, we offer a safe, effective and reliable tool to further enhance patient care with accurate transient local drug delivery. It is available in compliant and non-compliant versions.

Resources
Product Brochure

Key performance characteristics of the Protégé are :

Safe and easy drug delivery

  • No airborne particles and no premature release of Paclitaxel
  • Hydrophilic coating delivers Paclitaxel homogeneous to the vessel wall instantaneously upon contact
  • Hydrophilic coating delivers Paclitaxel without any excipient
  • Inflation for only 30 seconds ensures the drug delivery to the target lesion

Wing seal technology

  • Drug component encapsulated using Wing Seal Technology
  • Wings remain closed prior to inflation at Nominal Pressure
  • Ensures tight balloon wrapping for reduced crossing profile

Fast and complete re-endothelialization

  • Vessel healing not interrupted and stable within days after procedure
  • Re-endothelialization starts within days after procedure

No procedural limitations

  • Flexibility and characteristics of a usual workhorse PTCA balloon
  • No change in standard operating procedures or handling required
  • Multiple inflations will not lead to toxic level of Paclitaxel
  • Based on Blue Medical’s proven high-end workhorse PTCA catheter
  • Technology optimized to reach and cross the most difficult lesions
  • Optimal pushability and trackability due to balanced proximal and distal shaft transitions
  • Low profile tapered shaped design tip-to-balloon transition for smoother crossing results
  • Catheter length 154 cm- Useful in the Retrograde approach
  • Kissing balloon compatible with 6Fr Catheter
Protégé is a brand of Blue Medical, manufactured in Netherlands and it is EU-MDR certified.
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