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*.