Boston Scientific Receives Approval For TAXUS Liberte Stent System
Boston Scientific Corporation has received approval for the sale of its TAXUS Liberte paclitaxel-eluting coronary stent system in Canada. The Company reported that Health Canada's Therapeutic Products Directorate (TPD), the authority that regulates pharmaceutical drugs and medical devices, has approved its use. The Company said it plans to launch the product immediately in Canada.
"The TAXUS Liberte Stent is a major advance in stent development and raises the bar for drug-eluting stent systems," said Serge Doucet, M.D., Cathlab Director at the Montreal Heart Institute. "It offers enhanced ability to conform to the vessel wall and deliver across some of the most challenging lesions. This innovation is welcome news for interventional cardiologists and patients in Canada who suffer from coronary artery disease."
"This stent is designed specifically for improved drug elution and deliverability," said David McFaul, Boston Scientific Senior Vice President, International. "Coupled with our proven paclitaxel-eluting technology, TAXUS Liberte provides physicians with next-generation performance. We are delighted that Canadian physicians and patients can now benefit from this highly advanced technology for the treatment of coronary artery disease."
Currently the leading drug-eluting stents worldwide, TAXUS Stent Systems have been evaluated by the industry's most extensive randomized, controlled clinical trial program, as well as studied in more than 35,000 real-world patients enrolled in post-approval registries. To date, approximately four million TAXUS Stents have been implanted worldwide.
The TAXUS Liberte Stent has previously been approved for sale in Europe and other international markets and is currently awaiting approval by the U.S. Food and Drug Administration and is not available for sale in the United States.