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发表于 28-1-2013 22:19:49|来自:新加坡
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Biosensors Receives CE Mark Approval for BioFreedom™
Singapore, 28 January 2013 – Biosensors International Group, Ltd. (“Biosensors” or the “Company”,
Bloomberg: BIG SP Reuters: BIOS.SI SGX: B20), a developer, manufacturer and marketer of
innovative medical devices, today announced CE Mark approval for its polymer-free drug-coated
stent (DCS), BioFreedom™.
BioFreedom represents the latest development in Biosensors’ stent technology, featuring a microstructured abluminal surface which permits the controlled release of Biolimus A9™ (BA9™) without
the use of a polymer. BA9 is a highly lipophilic anti-restenotic drug developed by Biosensors
specifically for use with stents.
CE Mark approval for BioFreedom was supported by strong data from the BioFreedom First in Man
study. In this study BioFreedom was compared to Boston Scientific’s Taxus™ Liberté™ drug-eluting
stent (DES). At 12 months, BioFreedom demonstrated equivalent efficacy, measured by in-stent late
lumen loss, compared with Taxus Liberté, with a trend towards superiority. Median in-stent late
lumen loss in patients receiving BioFreedom was reduced to 0.17 mm as compared with a median instent late lumen loss of 0.35 mm in the Taxus Liberté group. Three year clinical results, presented at
the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in October 2012, showed
similar rates of MACE (Major Adverse Cardiac Events) between BioFreedom and Taxus Liberté, with
no evidence of stent thrombosis in either group.
To further evaluate BioFreedom in a larger patient population, Biosensors recently announced
initiation of enrolment in LEADERS FREE, the world’s first prospective, randomised double-blind trial
between a DCS and bare-metal stent (BMS), exclusively involving patients at high risk of bleeding.
The study has been designed to confirm that BioFreedom is as safe as a BMS in this patient group,
and can deliver the anti-restenotic benefit of a DES, with only a one-month course of dual antiplatelet therapy administered to all patients.
This trial will provide additional data to support the launch of BioFreedom in select markets during
2013. The full commercial launch is currently anticipated during 2014. |
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