Research & Development

 

The new Drug Coated Stent (DCS) : BioFreedom 

BioFreedom represents the latest development in Biosensors’ stent technology, featuring a micro-structured abluminal surface that permits the controlled release of Biolimus A9 (BA9) without the use of a polymer or other carrier. BA9 is a highly lipophilic anti-restenotic drug developed by Biosensors specifically for use with stents. In its First in Man (“FIM”) study, treatment with BioFreedom demonstrated excellent 12-month late lumen loss and sustained safety up to four years, including absence of definite and/or probable stent thrombosis.

Enrolment is now complete in LEADERS FREE, the world’s first prospective, randomised double-blind trial employing only a one-month course of dual anti-platelet therapy (DAPT) after implantation of an active stent. The study is focused on patients at high risk of bleeding, and has been designed to confirm that BioFreedom is as safe as a bare-metal stent (BMS) in this patient group, while delivering the anti-restenotic benefit of a drug-eluting stent (DES).


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 BioMimics 3D™, BioMatrix Flex™, BioMatrix Flex™BTK, BioMatrix NeoFlex™, BioMatrix™, Axxess™, BioFreedom™, Chroma™, BioStream™, BioPath™, Gazelle™, Juno™, S-Stent™, Powerline™, Quadrature Link™ and MultiPleat™, are not available for sale in the United States and certain other countries. All other trademarks are the property of their respective owners.

BioMatrix Flex, BioMatrix Flex BTK, BioMatrix NeoFlex, BioMatrix, Axxess, BioFreedom, Chroma, BioStream, BioPath, Gazelle, Juno, S-Stent, Powerline, Quadrature Link and MultiPleat are trademarks or registered trademarks of Biosensors International Group, Ltd. in the United States and certain other countries. BioMimics 3D and other cited trademarks are the property of their respective owners.