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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

tent percent diameter stenosis at nine months.

During the first nine months, 9.2 percent of patients receiving the Biosensors DES, and 10.5 percent of patients given the Cypher DES experienced a clinical adverse event that could be included in the primary composite endpoint, thus demonstrating that the Biosensors stent was non-inferior to the Cypher stent. A favorable trend towards the Biosensors stent was non-significant at the nine months follow-up endpoint. As anticipated, clinical event rates were higher in LEADERS compared with previous DES trials performed in patients with only on-label indications, because the LEADERS trial design permitted inclusion of any patient eligible for PCI. As a result, rates of death, myocardial infarction and stent thrombosis were similar for both stent types, but were 2.6% higher when compared to the earlier, less inclusive trials.

In the angiographic sub-group, there were no significant differences at 9 months between the in-stent percent diameter stenosis observed in the two patient groups, but there was a non-significant trend favoring the Biosensors stent.

"The results from LEADERS are very significant as they demonstrate for the first time that a drug-eluting stent with an abluminal biodegradable polymer is as safe and effective at nine months as a conventional drug-eluting stent with a durable polymer, considered to be the most effective, under conditions which resemble those of routine clinical practice", commented LEADERS Principal Investigator Professor Stephan Windecker, University Hospital, Bern, Switzerland. "Longer-term follow-up of the patients in LEADERS or studies of a similar nature are now needed to confirm the theoretical advantage of the abluminal biodegradable polymer in terms of reduced risk of late thrombosis."

Mike Kleine, President & CEO of Biosensors added, "We are tremendously encouraged by the results of LEADERS, believing this to be just the first in a series of studies whic
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SOURCE Biosensors International Group, Ltd
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