Research & Development


The new Drug Coated Stent (DCS): BioFreedom

BioFreedom represents the latest development in Biosensors stent technology and differentiates radically from current drug-eluting stent (DES).
BioFreedom is a polymer- and carrier-free stent coated with Biolimus A9™ (BA9), a drug developed by Biosensors specifically for use with stents.
BA9 is transferred rapidly (≈50 hours) from the micro-structured abluminal (outer) surface of the stent into the vessel wall, leaving only a bare metal stent (BMS).
The highly lipophilic properties of BA9 facilitates its uptake by the vessel wall allowing for local tissue warehousing and sustained release for up to 100 days.
In a typical DES, the antirestenotic drug is released by the polymer on the stent over a period of months.
With BioFreedom’s unique characteristics, the inhibition of restenosis is comparable with current DES, without the potential side effects of a polymer.

LEADERS FREE is the world’s first prospective, randomised double-blind trial of an active stent with only 1 month of dual anti-platelet therapy (DAPT).
The trial focused on high bleeding risk (HBR) patients, and was designed to confirm that BioFreedom is as safe as a BMS, while delivering the anti-restenotic benefit of a DES. The results were presented at TCT in October 2015.
Both primary endpoints (safety and efficacy at 1 year) were met with impressive statistical significance. BioFreedom showed superior efficacy with a reduction of target lesion revascularization (TLR) by 50%, as well as superior safety with a 29% risk reduction in the composite safety endpoint. 

CAUTION: 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 and endovascular products, including BioMatrix Flex™, BioMatrix Flex™ BTK, BioMatrix NeoFlex™, BioMatrix Alpha™, BioMatrix™, Axxess™, BioFreedom™, Chroma™, BioStream™, BMX-J®, Excel, BioPath™, Gazelle™, Juno™, S-Stent™, Powerline™, Quadrature Link™ and MultiPleat™, are not available for sale in the United States and certain other countries.

BioMatrix Flex, BioMatrix Flex BTK, BioMatrix NeoFlex, BioMatrix Alpha, BioMatrix, Axxess, BioFreedom, Chroma, BioStream, BMX-J, BioPath, Gazelle, Juno, S-Stent, Powerline, Quadrature Link, MultiPleat, Accutrans, Biotrans and SafetyWedge are trademarks or registered trademarks of Biosensors International Group, Ltd. All other cited trademarks are the property of their respective owners.