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Spirit clinical trial focuses on DES safety results

Boston Scientific : 23 May, 2007  (New Product)
Additional data from the Spirit First, II and III clinical trials reaffirms prior safety and and efficacy data for the Taxus Express2 Paclitaxel-Eluting Coronary Stent System and Xience V (Promus) Everolimus Eluting Coronary Stent System.
The Spirit trials focused on the Taxus Express2 Paclitaxel-Eluting Coronary Stent System and Xience V (Promus) Everolimus Eluting Coronary Stent System.

The Promus Stent is a private-labelled Xience V Stent, manufactured by Abbott and distributed by Boston Scientific.

Boston Scientific is the only company to offer the choice of two distinct drug-eluting Stent platforms.

The data were presented by Gregg W Stone, MD, chairman and chief medical officer of the Cardiovascular Research Foundation, Columbia University Medical Center, New York City, at the annual Paris Course on Revascularization (EuroPCR) in Barcelona.

The Spirit First three year clinical follow-up results provided further support for the safety and efficacy of the Xience V (Promus) Stent, with no additional MACE since one year follow up.

In addition, no acute, sub-acute or late Stent thrombosis was seen in either the Xience V (Promus) or BMS control group through three years.

Dr Stone's presentation also included results of a pooled analysis of previously reported Spirit II and III data, where Stent thrombosis rates were shown to be very low for both stents (0.45 percent for the Xience V (Promus) Stent and 0.25 percent for the Taxus Stent, p=0.59).

'It is reassuring to see that both stents performed exceptionally well in the Spirit Clinical Trials on multiple safety measures including Stent thrombosis', said Jeff Goodman, president of International for Boston Scientific.

'The data for these two drug-eluting Stent platforms continue to reinforce Boston Scientific's leadership position in drug-eluting Stent technologies'.

'We also look forward to Abbott presenting and publishing subset data from the Spirit Clinical Trials'.

The Promus Stent has CE Mark approval and is distributed in most European countries and other international markets.

The Xience V (Promus) Everolimus Eluting Coronary Stent System is an investigational device in the USA and not yet approved for sale.

It is currently under FDA review with an anticipated US launch in 2008.

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