BioFreedom is a polymer- and carrier-free Drug Coated Stent with BA9™ (DCS).
The combination of a selectively micro-structured abluminal surface (SMS) and Biolimus A9™ make BioFreedom a unique stent. At least 20% of PCI patients are High Bleeding Risk (HBR)1-9 requiring an individualized approach, BioFreedom provides a more appropriate treatment strategy.
The rapid 28 day transfer of BA9 to the coronary artery and rapid reendothelialization of the stented vessel, make BioFreedom the most relevant choice of stent for High Bleeding Risk (HBR) patients who cannot tolerate long dual antiplatelet therapy (DAPT).
The LEADERS FREE trial proved superior safety and efficacy of the BioFreedom DCS vs a BMS in the previously understudied and underserved HBR patient population.10
BioFreedom is now listed as stent of choice in ESC DAPT guidelines, for 1 month-ultra short DAPT in patients with stable CAD in whom longer DAPT regimes poses safety concerns*.
* European Heart Journal (2018)39, 213-254
1. Rao et al. AHJ 2013;166:273-281.e4
2. Rittger H et al. Herz 2014;39(2):212-8
3. Faxon et al. Circ Cardiovasc Interv 2011;4:522-34
4. De Biase et al. Transl Med 2015;11(3):14-23
5. To et al. Circ Cardiovasc Interv-2009;2:213-21
6. Wiviott et al. NEJM 2007;357:2001-15
7. Pilgrim et al. Circ Cardiovasc Interv. 2012;5:202-210
8. Shanmugam VB et al. Journal of Geriatric Cardiology 2015;12:174−184
9. Urban P. et al. Am Heart J 2013;165:704-9
10. Guistino et al. JACC 2015;65:1298–310