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Biosensors DES Demonstrates Equivalent Safety and Efficacy to Industry Leading DES in First 'Real World, All Comers' Clinical Study
Date:9/1/2008

MUNICH, Germany, September 1 /PRNewswire-FirstCall/ -- Biosensors International Group, Ltd ("Biosensors", "Company"), (Bloomberg: BIG:SP), (Singapore:B20) today announced that a next-generation drug-eluting stent, developed by Biosensors, has demonstrated equal safety and efficacy as compared to Johnson & Johnson's industry leading drug-eluting stent, CYPHER SELECT(TM) ("Cypher"), based upon nine-month clinical and angiographic follow-up data. The results of the landmark study were presented today at the 2008 European Society of Cardiology Congress and published concurrently on-line by the prestigious UK medical journal The Lancet.

LEADERS (Limus Eluted from A Durable versus ERodable Stent coating) is the first head-to-head randomized study between the two drug-eluting stent systems (DES) in a 'real world, all comers' population using clinical results as its primary endpoint.

This multi-centre European study randomized 1,707 patients eligible for percutaneous coronary intervention (PCI) for symptomatic coronary disease to receive either a Biosensors Biolimus-eluting DES with an abluminal biodegradable polymer coating, or a Cypher Sirolimus-eluting DES with a durable polymer. In total, 2,472 coronary lesions were treated. Inclusion criteria were broad, reflecting routine clinical practice, without limitations regarding type of coronary vessel, lesion length or number of treated lesions. Patient conditions known as "off-label indications", including acute coronary syndromes, saphenous vein grafts and previously treated lesions were also included in the trial.

The primary endpoint of the study was non-inferiority of the composite of cardiac death, myocardial infarction, and clinically-driven target vessel revascularization ("TVR") at nine months follow-up. In addition, 25 percent of all patients were randomly assigned to undergo angiographic follow-up at nine months. The principal endpoint of the pre-specified angiographic sub-group was in-s
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SOURCE Biosensors International Group, Ltd
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