Technology
Clinical data
IFU

IFU Release Date: PRO2.0201.12 08/2023

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. Unique on the market: Non-Compliant Drug Coated Balloon.

Supported by independent scientific evidence, we offer a safe, effective and reliable tool to further enhance patient care with accurate transient local drug delivery.

Resources
Product Brochure

Key performance characteristics of the Protégé NC are:

Safe 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 : Prevents premature paclitaxel release during handling
  • 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 non-compliant PTCA balloon
  • No change in standard operating procedures or handling required
  • No pre-dilatation required: tight lesion crossing does not influence drug delivery
  • Multiple inflations will not lead to toxic level of Paclitaxel based on blue medical’s proven high-pressure non-compliant 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

Clinical Data

Upper Extremity Function following Transradial Percutaneous Coronary Intervention: Results of the ARCUS Trial.
Zwaan E.M., Cheung E.S., et.al. J Interv Cardiol. 2022; 2022: 6858962.

Clinical Performance of a Paclitaxel Drug-Coated Balloon in Real-World Percutaneous Coronary Intervention Practice: The PEARL Registry.
Vlieger S., Cheng J.M., et al.  J INVASIVE CARDIOL 2022;34(6):E462-E468

Protégé NC is a brand of Blue Medical, manufactured in Netherlands and it is EU-MDR certified.
Share