Clinical Program

Taking the LEAD in DES Clinical Excellence

At Biosensors innovation is our driving force. This approach is applied to our comprehensive clinical trial program, created to provide physicians and stakeholders with robust data on the safety and efficacy of our products.

The studies in our clinical program are optimized to assess the safety and efficacy profiles of our latest-generation stent products in diverse patient populations. We work in partnership with the medical community and leading clinical investigators worldwide in developing innovative, new clinical trials covering our products.

The paradigm-shifting LEADERS trial was the first randomized, multicenter, all-comers trial to compare our biolimus-eluting stent with a market-leading sirolimus-eluting stent. The results were universally successful, documenting the equivalence and/or superiority of our stent design in both safety and efficacy variables.

We have access to databases containing data from more than 12,000 patients treated with our innovative technologies in clinical trials sponsored by Biosensors and its licensees. The clinical data has been gathered in broad patient populations, from simple to complex, including single de novo lesions, multiple vessel disease, acute coronary syndromes (incl. STEMI), bifurcations, left main, small vessels and extreme long lesions.  We have collected data in diabetic patients and in patients being treated for a restenosed saphenous vein graft.  Our database includes patients enrolled internationally from numerous countries in Europe, Latin America and Asia.

In the LEADERS trial, we use the latest assessment technologies like OCT (Optical Coherence Tomography) imaging and applied the highest analytical standards confirming the validity of our excellent and consistent outcomes. We work with leading physicians, clinical and technical experts as well as established academic institutions and core competency laboratories in analyzing and reporting our results. We are committed to the collection and publication of essential clinical knowledge using the most innovative clinical trial designs, so that clinicians and patients may assess patient benefit versus risk when choosing our products.*

Review the details of our exciting and comprehensive clinical trial programs.

* Data applicable to the stent used in the LEADERS trial.
6. BioMatrix Flex, BioMatrix, Axxess, Juno, Biolimus A9 and BA9 are trademarks or registered trademarks of Biosensors International Group, Ltd. in the United States and other countries. All cited trademarks are the property of their respective owners.

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.