Video: Boston Scientific Announces FDA Approval of Second-Generation TAXUS(R) Liberte(R) Drug-Eluting Stent
"The TAXUS Liberte stent represents our latest advance in drug-elutingstent technology," said Donald Baim, M.D., Chief Medical and ScientificOfficer of Boston Scientific. "This device has substantially thinner strutsand a more flexible cell geometry for improved deliverability, as well asuniform strut distribution designed specifically for drug elution. The TAXUSLiberte stent demonstrated similar late loss and target vesselrevascularization (TVR) as the TAXUS(R) Express2(TM) Paclitaxel-ElutingCoronary Stent System in the ATLAS Workhorse clinical trial, despite treatingmore challenging patients."
"We believe the approval of TAXUS Liberte is a clear indication that wehave made significant progress toward resolving the issues related to theCorporate Warning Letter," said Jim Tobin, President and Chief ExecutiveOfficer of Boston Scientific.
The TAXUS stent systems -- both Liberte and Express2 -- have beenevaluated by the industry's most extensive randomized, controlled clinicaltrial program, with follow-up to five years in some cases. These trialresults have been supplemented by data on more than 35,000 patients enrolledin post-approval registries. To date, approximately 4.6 million TAXUS stentshave been implanted globally, making them the world's most frequently useddrug-eluting stents.
The TAXUS Express2 stent (not the newer TAXUS Liberte stent) was used asthe control against the Xience(TM) V Everolimus-Eluting Coronary Stent Systemin the SPIRIT II and III trials. XIENCE is a trademark of the AbbottLaboratories group of companies.
The TAXUS Liberte Stent is not available for sale in Japan, where it isundergoing regulatory review.
Boston Scientific is a worldwide developer, manufacturer and marketer ofmedical devices whose products are used in a broad range of interventionalmedical specialties. For more information, please visit:www.bostonscientific.com.
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SOURCE Boston Scientific
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