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. 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.
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.
