Proven Safety of a DES with an Abluminal Biodegradable Polymer

Confirmed Safety

  • With a 16% reduction in MACE compared to the Cypher® Select™ stent at 2 years in LEADERS2
  • With no late or very late stent thrombosis in STEALTH I out to 4 years4

Mortality benefit

The BioMatrix Flex™ stent reduces the cardiac death rate by 50.5% compared to the Cypher® Select™ stent at 2 years3.

Superior strut coverage

10 times better strut coverage of the BioMatrix Flex™ stent than the Cypher® Select™ stent at 9 months5-6

  • The BioMatrix Flex™ stent achieves 96.4% of near to complete strut coverage

Superior stent apposition

More than 20 times better stent apposition of the BioMatrix Flex™ stent than the Cypher® Select™ stent at 9 months5-6

In the animal model, the BioMatrix Flex™ stent achieves a similar level of re-endothelialization compared to its bare metal stent platform

BA9™ drug/Biodegradable PLA technology demonstrates preserved vasomotion7

  • Abnormal vasomotion (vasoconstriction) was observed for the sirolimus eluting stent group after high pacing stimulation, while normal vasomotion (vasodilatation) was observed in the BA9™ eluting stent group

    • 2.
    Klauss, V., LEADERS, 2-year Clinical Follow-Up, oral presentation, TCT 2009
    3.
    Wykrzykowska, J., oral presentation, Late Breaking Trial Session, Euro PCR 2010
    4.
    Grube, E., Safety and Performance Evaluation of Biosensors Biolimus A9™ Eluting Stent (BioMatrix™) STEALTH I: a 4-year safety follow-up, e-poster, TCT 2008 – The BioMatrix™ stent was used in the STEALTH I clinical trial
    5.
    Di Mario, C., OCT: Differences between biodegradable and durable polymers – Insights from the LEADERS trial, oral presentation, TCT 2008
    6.
    Barlis, P. et al., An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting stent: a LEADERS trial sub-study; European Heart Journal (2010) 31, 165-176
    7.
    Hamilos, M. et al. on behalf of the Nobori Core investigators, Differential Effects of Drug-Eluting Stents on Local Endothelium-Dependent Coronary Vasomotion, J Am Coll Cardiol 2008 51:2123-2129

    CAUTION: 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 Flex™, BioMatrix™, 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, 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.