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What is BioFreedom™?

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 40%1 of PCI patients are High Bleeding Risk (HBR) 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.2

 

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*.

11524-000-EN - Rev.01 + 11881-000-EN - Rev.04
BioFreedom™
Movie - How does it work?
BioFreedom™
Main brochure

* European Heart Journal (2018)39, 213-254
1. 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
2. Garot P. et al. 2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents. JACC VOL.6 9, NO.2 , 2017
 

 

BIOFREEDOM™ FAMILY CLINICAL PROGRAM

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The law restricts these devices to sale by or on the order of a physician. Prior to use, it is important to read the "Instructions for Use" supplied with these devices for indications, contraindications, suggested procedures, warnings, and precautions.

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

BioMatrix NeoFlex, BioMatrix Alpha, BioFreedom, BioFreedom Ultra, Chroma, BioStream, BMX-J, BioPath, Juno, S-Stent, Powerline, Rise NC and Quadrature Link are trademarks or registered trademarks of Biosensors International Group, Ltd. ALLEGRA is a trademark or registered trademark of NVT AG. ALLEGRA™ is CE Mark approved (CE 0124). All other cited trademarks are the property of their respective owners.