NATICK, Mass., Boston Scientific Corporation announces the launch of the PROMUS Element™ Everolimus-Eluting Platinum Chromium Coronary Stent System in Japan.  The product was recently approved by the Ministry of Health, Labor and Welfare.  The PROMUS Element Stent System incorporates a platinum chromium (PtCr) alloy with an innovative stent design and an advanced catheter delivery system designed to provide physicians improved drug-eluting stent performance in treating patients with coronary artery disease.  The Company plans to begin marketing the product immediately in Japan.

"We are very pleased to launch the PROMUS Element Stent System to Japanese physicians and their patients," said Yusuke Naiki, President of Boston Scientific Japan.  "This everolimus-based stent system complements our broad coronary intervention portfolio and reinforces our global leadership in the drug-eluting stent market."

The PROMUS Element Stent uses a proprietary PtCr alloy designed specifically for coronary stenting, which enables enhanced visibility, less recoil, excellent conformability and higher radial strength.  It employs an advanced low-profile delivery system to enable precise stent placement across challenging lesions.  The everolimus drug and fluorinated copolymer used on the PROMUS Element Stent have been studied in multiple randomized clinical trials and registries.  The PROMUS Element Stent expands Boston Scientific's PtCr drug-eluting stent portfolio in Japan, which also includes the TAXUS® Element Paclitaxel-Eluting Platinum Chromium Coronary Stent System.

"This approval marks two important milestones for Boston Scientific," said Hank Kucheman, Chief Executive Officer of Boston Scientific.  "First, the PROMUS Element Stent platform is now approved in every major market worldwide.  Second, we have begun the last phase of our transition to higher margins on our everolimus stent offering as we shift to the internally manufactured PROMUS Element Stent.  Boston Scientific remains the only company to offer physicians a choice of two proven drug and polymer combinations on an innovative coronary stent platform."

The Company received CE Mark approval for the PROMUS Element Stent System in 2009 and for the PROMUS Element Plus Stent System in 2011.  In the U.S., the PROMUS Element Plus Stent System was approved by the Food and Drug Administration (FDA) in 2011.  The TAXUS® Element™ Paclitaxel-Eluting Stent System received Japan approval in 2011 and CE Mark approval in 2010.  It is commercialized in the U.S. as the ION™ Paclitaxel-Eluting Stent System, where it received FDA approval in 2011.

Source: Boston Scientific Corporation