Protégé

Paclitaxel Coated Coronary Balloon Dilatation Catheter

PACLITAXEL – Drug of Choice for DCB in Coronary Interventions with Large Clinical Evidence*

*European Heart Journal (2018)00, 1-23 Doi:10.1093/eurheartj/ehy394 **Clin Res Cardiol. 2015; 104: 217-25
***Speck, U., et al. (2006). “Neointima Inhibition: Comparison of Non–Stent-based Local Drug Delivery and a Drug-eluting Stent in Porcine Coronary Arteries.” RSNA.
****Biotechnology and Bioprocess Engineering 17: 912-924 (2012) DOI 10.1007/s12257-011-0571-z,
Scheller B, Vukadinovic D, Jeger R, et al. Survival After Coronary Revascularization With Paclitaxel-Coated Balloons. J Am Coll Cardiol. 2020;75(9):1017-1028.

Paclitaxel proven more Efficacious than Limus as a choice of Drug in DCB

*Ninomiya, K. et al. (2023). Sirolimus-Coated vs. Paclitaxel-Coated Balloon in Small Vessels. J Am Coll Cardiol Intv, 16(23), 2884–2896. doi:10.1016/j.jcin.2023.09.026
**Raynor, B. P. et al. (2023). Biolimus A9™ DCB for In-Stent Restenosis: REFORM Trial Design. Cardiovasc Revasc Med, 56, 75–81. doi:10.1016/j.carrev.2023.06.004

UNIQUE DRUG APPLICATION

During the production process the balloon material is inflated & folded

Paclitaxel is applied within the folds of a PVP-coated (hydrophilic) balloon, reducing exposure and preventing loss prior to inflation

DRUG RELEASE

The coating acts as sponge which elutes the drug only when pressure is applied

Paclitaxel is released from the coating after first inflation to the target vessel

WING SEAL TECHNOLOGY
  • Protects the drug between the balloon folds during advancement, resulting in negligible drug loss prior to inflation
  • The corrugation increases flexibility of the balloon ensuring better trackability & crossability
  • Tight wrapping prevents the balloon unfolding during advancement
M3i TECHNOLOGY
  • Multiple Drug Release*
    Drug release up to 3 times with the same device when clinically indicated
  • Interval Plot of Acute tissue levels of Paclitaxel over multiple inflations
keyboard_arrow_up