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What is BioFreedom™ Ultra?

BioFreedom™ Ultra is a polymer- and carrier-free Drug Coated Stent with BA9™ (DCS).

BioFreedom™ Ultra is a novel CoCr 84µm§ stent, that will optimize the PCI procedure for HBR patients by simplifying stent choice pre-procedure based on the LEADERS FREE legacy, enhancing procedure success thanks to the stent and delivery system design3 and maximizing outcomes for High Bleeding Risk patients treated with one month DAPT3.

The combination of a selectively micro-structured abluminal surface (SMS) and Biolimus A9™ make BioFreedom™ Ultra a unique stent. Both iterations of the BioFreedom™ stent use Biosensors International patented SMS process to allow a uniform dose of BA9™ to be coated on to the abluminal surface of the stent, standardizing the drug dose between the two devices. BioFreedom™ is the predicate device of BioFreedom™ Ultra allowing to leverage the legacy of the LEADERS FREE clinical trial program.

At least 40%1 of PCI patients are High Bleeding Risk (HBR) requiring an individualized approach, BioFreedom™ Ultra 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™ Ultra 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 population2.

BioFreedom™, predicate device to BioFreedom™ Ultra, is 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?
LEADERS FREE
Webinar - PCR 2020 e-Course
As easy as 1,2,3! Evidence based PCI in Patients at High Bleeding Risk
* European Heart Journal (2018)39, 213-254
§. Struts for specific stent diameter (small vessel)
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. Data from BioFreedom. BioFreedom is the predicate device of BioFreedom Ultra. 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
3. Data from BioFreedom Ultra. Bolimus-A9 coated thin Strut Stents in High Bleeding Risk Patients Evidence from the LEADERS FREE III Study. F.R.Eberli et al., Presented at PCR eCourse June 2020
 

 

BIOFREEDOM™ FAMILY CLINICAL PROGRAM

CAUTION: Please note that the following pages are exclusively reserved for Health Care Professionals in countries with applicable health authority product registrations. To the extent this site contains information intended for use by licensed medical professionals, such materials are not intended to offer professional medical advice. Prior to use, please consult device labeling for prescriptive information and operating instructions. Please contact your Biosensors International representative for availability or the products and registration status.

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, 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.

BioMatrix NeoFlex, BioMatrix Alpha, BioFreedom, BioFreedom Ultra, BMX-J, Juno, S-Stent and Rise NC are trademarks or registered trademarks of Biosensors International Group, Ltd. ALLEGRA is a trademark or registered trademark of NVT AG. All other cited trademarks are the property of their respective owners.