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At least 40% of PCI patients are High Bleeding Risk (HBR) where there is a need to avoid prolonged dual antiplatelet therapy (DAPT).1-9

The BioFreedom™ Drug-Coated Stent (DCS) is significantly safer and significantly more efficacious than a BMS in High Bleeding Risk patients, with a DAPT regime of only one month, the shortest DAPT regime mandated for all patients in a published, double-blind randomized controlled trial.10

By directly delivering BA9™ - an effective anti-restenotic therapy - without polymer or carrier, becoming a BMS at 28 days, the DAPT regime can be shortened when treating patients with the BioFreedom™ stent.10,11

 

BioFreedom HBR

In LEADERS FREE, High bleeding risk patients include, but are not exhaustively: Age >75 OACs, Renal Failure, planned surgery within the next 12 months, anemia of recent TF, Cancer, hospitalisation for bleeding, poor DAPT compliance, NSAIDS steroids, thrombocytopenia, stroke <1 year, severe liver disease, prior intracerebral bleed.

 

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*.

11523-000-EN - Rev.01 + 11524-000-EN - Rev.01 + 11881-000-EN - Rev.04
BioFreedom™
Movie - Who are HBR Patients?
BioFreedom™
HBR patients brochure

*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. Urban P et al. N Engl J Med 2015;373:2038-47
11. Ueki et al. Validation of Bleeding Risk Criteria (ARC-HBR) in Patients Undergoing Percutaneous Coronary Intervention and Comparison with Contemporary Bleeding Risk Scores. EuroIntervention. 2020 Feb 18. doi: 10.4244/EIJ-D-20-00052

 

BIOFREEDOM™ FAMILY CLINICAL PROGRAM

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Biosensors’ interventional cardiology products, including BioMatrix NeoFlex™, BioMatrix™ Alpha, BioFreedom™, BioFreedom™ Ultra, BMX-J® and RISE™ NC, are not available for sale in the United States and certain other countries. ALLEGRA™ is a product of NVT GmbH. Blue Sail Medical Co., Ltd is the ultimate parent company of NVT GmbH and Biosensors International Group, Ltd. and its subsidiaries are collaborating for the commercialization of the ALLEGRA™ device.

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